Cardiovascular Preventative medicine Respiratory
Smoking cessation
Last revised in January 2026
Tobacco is smoked to obtain nicotine, principally to relieve symptoms of nicotine withdrawal.
Smoking cessation: Summary
- Smoking cessation refers to activities that aim to support people who smoke to stop smoking.
- All people who smoke should be advised to quit.
- Healthcare professionals should opportunistically ask people if they smoke during a consultation. If the person does smoke, very brief advice (VBA) for smoking cessation should be provided.
- If a person smokes, it is important to find out about their:
- Smoking behaviour.
- Level of nicotine dependence.
- Previous quitting attempts.
- For adult smokers wishing to quit, the preferred management is referral to the local NHS Stop Smoking Services. If they decline referral they should be:
- Informed about sources of information and support for smoking cessation.
- Offered practical advice.
- Advised to stop abruptly.
- Offered drug treatment to reduce withdrawal symptoms.
- Reviewed 2 weeks after stopping smoking, and the carbon monoxide (CO) level measured at 4 weeks. Thereafter, professional judgement should be used to decide the number, timing and frequency of appointments offered.
- If the person wishes to use e-cigarettes, they should be advised to use a licenced stop smoking medicine instead. If the person prefers to use e-cigarettes, they should be given information about these, support, and offered referral to the local stop smoking service.
- If an adult does not want to or is not ready to stop smoking, they should be asked whether they would like to try a harm reduction approach, such as:
- Stopping smoking, but continuing to use NRT.
- Cutting down before stopping smoking, with or without NRT.
- Smoking reduction, with or without NRT.
- Temporary abstinence from smoking, with or without NRT.
- NRT may be used as long as necessary to prevent relapse.
- People who smoke from the following groups should be strongly encouraged to take up referral to the local NHS stop smoking service:
- Pregnant women (including pregnant women who have stopped smoking in the past 2 weeks or who have a CO reading of 4 ppm or more.
- Mothers of young children, especially breastfeeding women.
- Young people aged 12-17.
- If a pregnant or breastfeeding woman or young person is unwilling or unable to be referred:
- They should be offered practical advice to help them stop smoking.
- The risks and benefits of NRT should be discussed.
- Professional judgement should be used when deciding whether to prescribe NRT to pregnant women or young people who show strong evidence of nicotine dependence.
- If a person does not want to take any action to stop smoking, they should be advised to seek help if they decide to stop smoking in the future. They should be asked about their smoking status next time they are seen.
Have I got the right topic?
From age 12 years onwards.
This topic is largely based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and Standard treatment programme [NCSCT, 2019a], the Royal College of Physicians (RCP) report Nicotine without smoke: tobacco harm reduction [RCP, 2016], a health technology assessment Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study [Dobbie, 2015], the Scottish Intercollegiate Guidelines Network (SIGN) guideline Risk estimation and the prevention of cardiovascular disease [SIGN, 2017], and evidence from Cochrane systematic reviews [Cahill, 2013; Cahill, 2016; Stead, 2016; Hartmann-Boyce, 2018; Hartmann-Boyce, 2019; Lindson, 2019a; Lindson, 2019b; Howes, 2020; Hartmann-Boyce, 2022].
This CKS topic covers the management of people that smoke who present in primary care. This includes the management of pregnant or breastfeeding women and of young people age 12-17.
This CKS topic does not cover interventions used in specialist smoking cessation clinics.
The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.
How up-to-date is this topic?
Changes
January 2026 — minor update. Added detail to advise that although e-cigarettes cannot currently be prescribed or supplied by NHS smoking cessation clinics the majority of local authority smoking cessation clinics do provide them as part of a harm reduction approach.
Previous changes
May 2025 — minor update. QOF indicators updated in line with the NHS England Quality and Outcomes Framework guidance for 2025/26.
April 2025 — minor update. The recommendations on vaping in pregnancy have been clarified and detail added to the basis for information section.
February 2025 — minor update. Added information on the potential use of cytisinicline as a stop smoking intervention to align with the updated NICE guideline NG209 Tobacco: preventing uptake, promoting quitting and treating dependence
August 2024 — minor update. Alopecia added as an adverse effect of bupropion, in line with the manufacturer's updated SPC.
May 2024 — minor update. Removed the information regarding the lack of provision of e-cigarettes from smoking cessation clinics.
March 2024 — minor update. Added information about the risk of panic attacks with bupropion in line with an update of the manufacturer's SPC.
September 2023 — minor update. Change of wording in pregnancy follow-up to align with wording elsewhere in the topic regarding definition of non-smoker.
April 2023 — reviewed. A literature search was conducted in March to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. Minor changes to prescribing information in line with updated manufacturer guidance, and the British National Formulary. The carbon monoxide breath test result that should be used to identify women who require referral to NHS Stop Smoking Services has been changed from 7 ppm and above to 4 ppm and above.
March 2023 — minor update. Added information about the risk of bupropion unmasking Brugada syndrome in line with an update of the manufacturer's SPC. Caution is advised in at risk patients.
December 2022 — minor update. Updated the quality standards in line with the publication of NICE, 2022 QS207 Tobacco: treating dependence.
August 2022 — minor update. Added information relating to the Allen Carr Easyway seminar programme. Added information about the lack of availability of varenicline until further notice.
September 2021 — minor update. History of epilepsy added to the cautions section for nicotine replacement therapy in line with updated manufacturer's SPC.
November 2020 — minor update. Risk of serotonin syndrome if selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors are taken concurrently with bupropion has been added in line with updated manufacturer's SPC.
March 2018 — reviewed. A literature search was conducted in February to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. There have been minor structural changes to the topic and information on Very Brief Advice on smoking cessation for adults and pregnant women, and recommendations regarding e-cigarettes have been added.
September 2017 — QOF indicators were updated as per the 2017/18 QOF recommendations.
December 2016 — minor update. Information on a possible drug interaction with bupropion and digoxin has been added to the drug interactions section of this topic, in line with the manufacturer's Summary of Product Characteristics ABPI, 2016.
August 2014 — minor update to the text to reflect an update to the Summary of Product Characteristics for NiQuitin® patches that the dose should be reduced or patches discontinued if there is a significant increase in cardiovascular or other effects attributable to nicotine.
April 2014 — minor update to the text to reflect an update to the Summary of Product Characteristics for NiQuitin® that seizures have been reported (frequency unknown).
February 2014 — minor update to the prescribing information for nicotine gum to reflect an update in the manufacturer's Summary of Product Characteristics about cardiovascular risks.
January 2014 — minor update. Formatting errors corrected.
June 2013 — minor update. The 2013 QOF options for local implementation have been added to this topic.
October 2012 — reviewed. A literature search was conducted in September 2012 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic. Recommendations have been amended as a result of the extended indications for nicotine replacement therapy (NRT). In addition to being used to relieve and/or prevent craving and nicotine withdrawal symptoms in smokers wishing to quit abruptly, NRT can also be used to reduce the amount smoked prior to quitting, to assist smokers who want (or need) to abstain from smoking temporarily (for example during enforced abstinence [such as on a long flight or in hospital] or in the company of non-smokers), and as a safer alternative to smoking.
November 2016 — minor update. The basis for recommendation for adverse effects of varenicline has been updated with information from a randomised controlled trial, which found that varenicline did not significantly increase the risk of neuropsychiatric events in people with or without a history of psychiatric disorder, compared with nicotine patches or placebo.
April 2012 — minor update. The 2012/2013 QOF indicators have been added to this topic.
June 2011 — minor update. The 2011/2012 QOF indicators have been added to this topic.
March 2011 — topic structure revised to ensure consistency across CKS topics — no changes to clinical recommendations have been made.
March 2011 — minor update. Missing QOF indicators added.
October 2009 — minor update to include new information from the Medicines and Healthcare products Regulatory Agency (MHRA) regarding varenicline and suicidal thoughts and behaviour, and regarding drug interactions with smoking cessation.
May 2009 — updated to include the indicators related to smoking cessation in the Quality and Outcomes Framework (QOF) of the General Medical Services (GMS) contract in the Goals and outcome measures section.
February 2009 — minor typographical correction.
August 2008 — minor update to include updated advice from the Medicines and Healthcare products Regulatory Agency (MHRA) regarding varenicline and suicidal thoughts and behaviour.
November 2007 to April 2008 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence.
March 2008 — Correction to the title of one varenicline prescription. Change in text to read 500 mcg instead of 500 mg.
July 2007 — Minor update to text to include new advice from the NICE technology appraisal guidance on the use of varenicline for smoking cessation.
July 2007 — Minor update to text, incorporating MHRA (2005) advice, which states that nicotine replacement therapies may be used in combination.
July to September 2005 — reviewed. Validated in December 2005 and issued in February 2006.
May 2002 — reviewed. Validated in June 2002 and issued in July 2002.
April 2002 — updated to include Guidance on the use of nicotine replacement therapy and bupropion for smoking cessation, Technology Appraisal Guidance No. 39, issued by the National Institute for Health and Care Excellence.
April 2001 — updated to include the amendment of Schedule 10 to the NHS (General Medical Services) Regulations 1992 permitting the full range of nicotine replacement products to be prescribed on NHS prescriptions.
October 2000 — updated to include information and prescriptions for bupropion.
November 1998 — written. Validated in March 1999 and issued in May 1999.
Update
New evidence
Evidence-based guidelines
- NICE guideline NG209 Tobacco: preventing uptake, promoting quitting and treating dependence NICE, 2025
- WHO (2025) WHO report on the global tobacco epidemic, 2025: warning about the dangers of tobacco. World Health Organisation. https://www.who.int [Free Full-text]
HTAs (Health Technology Assessments)
No new HTAs since 1 April 2023.
Economic appraisals
No new economic appraisals since 1 April 2023.
Systematic reviews and meta-analyses
- Theodoulou, A., Chepkin, S.C., Ye, W., et al. (2023) Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Library https://www.cochranelibrary.com/ [Free Full-text]
- Livingstone-Banks, J., Fanshawe, T.R., Thomas, K.H., et al. (2023) Nicotine receptor partial agonists for smoking cessation. Cochrane Library https://www.cochranelibrary.com/ [Free Full-text]
- RCP (2024) E-cigarettes and harm reduction: An evidence review. Royal College of Physicians. [Free Full-text]
- DBT (2024) Cytisine for smoking cessation. BMJ. https://dtb.bmj.com/ [Abstract]
- Khalifeh, M., Ginex, P., Boffetta, P. (2024) Reduction of head and neck cancer risk following smoking cessation: a systematic review and meta-analysis. BMJ Open. https://journals.bmj.com/home [Free Full-text]
Primary evidence
- Auer, R., Schoeni, A., Humair, J., et al. (2024) Electronic Nicotine-Delivery Systems for Smoking Cessation. NEJM. [Abstract]
- Cinciripini, P. M., Green, C. E., Shete, S., et al. (2024). Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial. JAMA. [Abstract]
- Hopkinson, N. S., Vrinten, C., Parnham, J. C., et al. (2024). Association of time spent on social media with youth cigarette smoking and e-cigarette use in the UK: a national longitudinal study. Thorax. [Abstract]
- Tuisku, A., Rahkola, M., Nieminen, P. (2024). Electronic Cigarettes vs Varenicline for Smoking Cessation in Adults: A Randomized Clinical Trial. JAMA Internal Medicine. [Abstract]
- NHS Digital (2024) Smoking, drinking and drug use among young people in England. NHS Digital. [Abstract]
- Cinciripini, P.M., Kypriotakis, G., Blalock, J.A., et al. Survival Outcomes of an Early Intervention Smoking Cessation Treatment After a Cancer Diagnosis. JAMA Oncology. https://jamanetwork.com [Free Full-text]
- Rigotti, N. A., Benowitz, N. L., Prochaska, J., Leischow, S., Nides, M., Blumenstein, B., ... & Jacobs, C. (2023). Cytisinicline for smoking cessation: a randomized clinical trial. JAMA, 330(2), 152-160. [Abstract]
- WHO (2025) WHO global report on trends in prevalence of tobacco use 2000–2024 and projections 2025–2030. World Health Organisation https://www.who.int [Free Full-text]
New policies
No new policies since 1 April 2023.
New safety alerts
No new safety alerts since 1 April 2023.
Changes in product availability
- New product cytisine 1.5 mg tablets are indicated for Smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking. See more here.
Goals and outcome measures
Goals
To support primary healthcare professionals to:
- Encourage people who smoke tobacco to quit.
- Maximize the chances of people succeeding to quit.
- Prevent relapses.
Outcome measures
No outcome measures were found during the review of this topic.Audit criteria
No audit criteria were found during the review of this topic.QOF indicators
Table 1. Indicators related to smoking cessation in the Quality and Outcomes Framework (QOF) of the General Medical Services (GMS) contract.
| Indicator | Points | Payment stages |
|---|---|---|
| SMOK002 The percentage of patients with any or any combination of the following conditions: CHD, PAD, stroke or TIA, hypertension, diabetes, COPD, CKD, asthma, schizophrenia, bipolar affective disorder or other psychoses whose notes record smoking status in the preceding 12 months | 25 | 50–90% |
| SMOK004 The percentage of patients aged 15 or over who are recorded as current smokers who have a record of an offer of support and treatment within the preceding 24 months | 12 | 40–90% |
Data from: [NHS England, 2025] | ||
QIPP - Options for local implementation
No QIPP indicators were found during the review of this topic.NICE quality standards
- People are asked if they use tobacco at key points of contact with a health or social care professional.
- People who use tobacco receive advice on quitting.
- People who want to stop using tobacco are offered tobacco cessation support and treatment by a healthcare professional.
- People who do not want, or are not ready, to stop using tobacco in one go receive support to adopt a harm-reduction approach.
- People who smoke receive treatment to stop smoking on admission to hospital.
Background information
What withdrawal symptoms is a person likely to experience when they stop smoking?
- Withdrawal symptoms are the physical and mental changes that a person may experience when they stop smoking.
- These include irritability, frustration, anger, anxiety, difficulty concentrating, increased appetite, restlessness, depressed mood, and insomnia.
- They are usually temporary and are caused by physical or psychological adaptation to long-term cigarette use.
- Weight gain is usually a concern for people who want to stop smoking. However, it presents a minor health risk when compared with the risk of continued smoking:
- Weight gain is often progressive for a number of years following cessation, and on average ex-smokers gain 5-9 kg if no attempt is made to eat a healthy diet and exercise. Weight gain is less likely while using drug treatments to help stop smoking.
- There is no strong evidence to show that exercise has a positive effect on cigarette cravings and withdrawal symptoms.
- A 2019 Cochrane review pooled data from 21 trials (including 6607 participants) comparing exercise versus no exercise intervention, on smoking cessation outcomes, and found no evidence for an effect of the exercise intervention on smoking cessation.
- Improved lung function and some of the other health benefits of giving up smoking are likely to make exercise easier and more beneficial.
What is the prevalence of smoking?
- Smoking prevalence in the UK has fallen from 51% of men and 41% of women in 1972, to 15.1% of men and 11.5% of women in 2021 [RCP, 2016; ONS, 2022a].
- This equates to 13.3% of the UK adult population (around 6.6 million people), which is a reduction of more than 6.9% since 2011.
- The prevalence of smoking is higher amongst certain sectors of the community:
- Bangladeshi, Irish, and Pakistani men and Black Caribbean and Irish women [PHE, 2015a].
- Lesbian, gay, and bisexual people [DH, 2017].
- Around 40% of people with serious mental health problems smoke [NHS Digital, 2016; PHE, 2020].
- The prevalence of smoking is strongly and directly related to all measures of deprivation in the UK [RCP, 2016].
- The prevalence of smoking among people in higher managerial and professional occupations in the UK is around 9-10%, and around 24-26% in people in routine and manual occupations [ONS, 2022b].
- Around 40% of unemployed people smoke [RCP, 2016].
- At the end of 2021/2022, 9.1% of pregnant women were known to be smokers at the time of delivery, this compares to 15.8% in 2006/07 [NHS Digital, 2022a].
- Overall the prevalence of smoking in children is falling, and in 2021 it was estimated that 2% of boys aged 11-15, and 4% of girls were current smokers [NHS Digital, 2022b].
- Young people are more likely to start smoking if they live with someone who smokes or if there is someone who smokes in their social environment [RCP, 2016].
- In Scotland in 2021, 2% of children lived in housing in which someone regularly smoked inside, this compares to 12% in 2012 [Scottish Health Survey, 2021].
- Around 60% of people who smoke say they would like to stop, 10% of whom intend to do so within the next three months [PHE, 2019].
- It is estimated that around half of all cessation attempts are undertaken unaided, despite this being the least effective method.
- Use of over-the-counter nicotine replacement products increase the likelihood of successfully stopping smoking by 150% in comparison with unaided cessation. The use of prescribed smoking cessation therapies increases the likelihood by 200%, and combining smoking cessation aids with expert support from local stop smoking services increases the likelihood by 300%.
What are the harms caused by smoking?
- Smoking is the main cause of premature death and preventable illness in the UK [PHE, 2019].
- People who smoke have a 50% chance of dying prematurely (on average 10 years earlier) due to smoking [PHE, 2015b].
- After the age of 35 years, a person loses 3 months of life expectancy for every year of continued smoking [Doll, 1994].
- In 2019, 15% of all deaths in adults aged 35 and over in England were attributed to smoking [ASH, 2021a].
- Smoking accounts for approximately 122,000 deaths per year [Peto, 2015].
- Three causes account for 70% of these deaths: lung cancer, chronic obstructive pulmonary disease (COPD), and vascular disease.
- People who smoke spend a significant proportion of their life in poorer health than people who do not smoke [PHE, 2015b].
- For every death caused by smoking, it is estimated that approximately 20 smokers will be suffering from a smoking-related disease, and the cost of smoking to the National Health Service in England is estimated to be £2.5 billion a year [ASH, 2021a].
- Smoking causes, or is associated with, a number of health problems, including:
- Cancer — it is estimated that smoking is responsible for almost one-fifth of new cancer diagnosis in the UK every year, and 7% of all cancer deaths [ASH, 2017].
- Complications in pregnancy and labour — smoking increases the risk of [NCSCT, 2014; NCSCT, 2016a; RCOG, 2020]:
- Maternal deep vein thrombosis and pre-eclampsia.
- Preterm birth.
- Premature rupture of membranes.
- Placental abruption.
- Placenta praevia.
- Ectopic pregnancy.
- Miscarriage.
- Fetal/infant complications — maternal smoking increases the risk of [WHO, 2013; NCSCT, 2014; RCOG, 2020; OHID, 2022a]:
- The child having behavioural problems (such as attention and hyperactivity problems), learning difficulties, reduced educational performance, and childhood respiratory problems.
- The child developing diabetes or obesity in later life.
- Infant mortality.
- Sudden infant death syndrome (SIDS).
- Stillbirth.
- Birth defects, such as cleft lip.
- Intrauterine growth restriction.
- Low birth weight — babies born to mothers who smoke are on average 200-250 g lighter than those whose mothers do not smoke.
- Adverse effects on other people — second-hand smoke is a carcinogen and there is no safe level of exposure [US Surgeon General, 2006]. Exposure to second-hand smoke can:
- Exacerbate respiratory symptoms and trigger asthma attacks [ASH, 2020b; CDC, 2022].
- Increase the risk of smoking-related diseases, particularly lung cancer and heart disease [RCP, 2005; ASH, 2020b].
- Increase the risk of SIDS, and the risk developing asthma, otitis media, chest infections, and meningitis in children the first years of life [RCP, 2010; ASH, 2020b].
- Affect the developing fetus, increasing the risk of low birth weight, congenital anomaly, stillbirth, and babies being born with a smaller head circumference [ASH, 2020b].
- Adverse outcomes following surgery — smoking is associated with adverse outcomes following surgery, such as [Delgado-Rodriguez, 2003; Theadom, 2006]:
- Delayed wound healing.
- Infections.
- Prolonged hospital stay.
- Repeated admissions after surgery.
- Lower survival rates.
- Other health problems — smoking causes [PHE, 2014; Peto, 2015; ASH, 2020c; ASH, 2020d; ASH, 2021b; ASH, 2021c]:
- Cardiovascular disease — 20% of all deaths from cardiovascular disease are due to smoking.
- Respiratory diseases, such as COPD — 40% of all respiratory deaths are due to smoking. Smoking triggers the development of asthma and exacerbates symptoms and increases the risk of developing pneumonia and tuberculosis.
- Stomach and duodenal ulcers.
- Erectile dysfunction.
- Male and female infertility.
- Progressive harm to the musculoskeletal system — smoking is a risk factor for osteoporosis, and there is an association between smoking and an increased risk of bone fracture. It is a cause of rheumatoid arthritis, especially among men.
- Progressive harm to the cognitive system. People who smoke are over 50% more likely to develop cognitive impairment than those who do not. Smoking is an important environmental risk factor for the development of dementia, due to the increased vascular risk.
- Smoking may be a risk factor for developing multiple sclerosis (MS), with evidence suggesting smoking rates are higher among people with MS than those seen in the general population.
- Cataracts and age-related macular degeneration.
- Periodontal disease and tooth decay.
- An increased risk of developing meningococcal disease.
- An increased risk of developing nephropathy and neuropathy for people with diabetes mellitus. There is also an association between smoking and an increased risk of retinopathy.
Benefits of stopping smoking
- The benefits of stopping smoking begin as soon as a person ceases to smoke; these are outlined in Table 1.
- Stopping smoking reduces the risk of:
- Death and ill health due to smoking-related diseases, particularly lung cancer, chronic obstructive pulmonary disease, and heart disease.
- Stopping smoking at age 60, 50, 40, or 30 adds about 3, 6, 9, or 10 years of life expectancy respectively [Doll, 2004].
- A prospective study of UK women (n= 1.2 million) showed that stopping smoking before the age of 40 avoids over 90% of the increased risk of dying caused by continuing to smoke [Pirie, 2013].
- For people who stop smoking before the age of 50 years, the risk of dying of smoking-related disease is reduced by 50% [PHE, 2015b].
- Smoking-related diseases in other people exposed to environmental tobacco smoke, particularly lung cancer and heart disease [ASH, 2020b; BMJ Best Practice, 2023].
- Exposure to other people’s smoke increases the risk of lung cancer in non-smokers by 20-30%, coronary heart disease by 25-35%, breast cancer by 67%, and cervical cancer by 40% [ASH, 2020b].
- Harms to children exposed to environmental tobacco smoke — passive smoking is estimated to cause around 165,000 new cases of disease, predominantly middle-ear disease and respiratory infections, generating over 300,000 primary care consultations and 9500 hospital admissions in the UK each year [RCP, 2016].
- Children in the same family starting smoking — children living with parents who smoke are almost three times more likely to smoke than children living with parents who do not smoke [ASH, 2019].
- There is no safe level of smoking during pregnancy, and the earlier in pregnancy a person is able to stop smoking, the greater the benefit. However, several harmful fetal effects (e.g. low birth weight, stillbirth, and placental abruption) are known to be increased by smoking in the second and third trimester of pregnancy. Therefore, stopping smoking at any time during pregnancy is likely to be beneficial to some extent [RCOG, 2020].
- If a woman stops smoking in the first 3 months of pregnancy, her risk of having a low birth weight baby will be similar to that of a non-smoker [RCP, 2000].
- Death and ill health due to smoking-related diseases, particularly lung cancer, chronic obstructive pulmonary disease, and heart disease.
Table 1. Benefits from smoking cessation with time since quitting.
Time since quitting | Benefits |
|---|---|
| 20 minutes | Pulse return to normal. |
| 8 hours | Oxygen levels return to normal and carbon monoxide levels in the blood reduce by half. |
| 48 hours | Carbon monoxide is almost eliminated from the body. Lungs start to clear out smoking debris. The ability to taste and smell improves. |
| 72 hours | Breathing is easier. Bronchial tubes begin to relax and energy levels increase. |
| 2–12 weeks | Circulation improves. |
| 3–9 months | Coughing and wheezing declines. |
| 1 year | Excess risk of heart attack reduces by half. |
| 10 years | Risk of lung cancer falls to about half that of a continuing smoker. |
| 15 years | Risk of heart attack falls to the same level as someone who has never smoked. |
| Source: [ASH, 2020a] | |
Management
Scenario: Assessment for smoking cessation
From age 12 years onwards.
How should I identify smokers and deliver brief advice on smoking cessation?
- Ask people at every opportunity if they smoke, and advise them to stop smoking in a way that is sensitive to their needs and preferences.
- If the person smokes, deliver very brief advice (VBA).
- Ask about current and past smoking behaviour.
- Provide verbal and written information on the risks of smoking and the benefits of stopping smoking.
- Advise on the options for quitting smoking including behavioural support, medication, and e-cigarettes. The most successful approach to stopping smoking is a combination of smoking cessation therapies with specialist support.
- Refer the person to their local stop smoking service (if they wish to stop smoking).
- For information on how to assess people who wish to stop smoking (and do not wish to attend a stop smoking service), see the section on Assessment.
- For people who do not wish to stop smoking:
- Advise them to think about doing so, and encourage them to return if they decide they would like to stop smoking in the future.
- Ask them about adopting a harm reduction approach.
- Record the person's smoking status and at every opportunity ask them about it again in a way that is sensitive to their preferences and needs.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], and the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014].
Very brief advice
- In order to be effective, brief interventions need to include an offer of help [NCSCT, 2014].
- Smokers, who are offered help by their GP, rather than only advice to stop, are twice as likely to make a quit attempt.
- Very brief advice (VBA) based upon Ask, Advise, Act offers a quick and effective approach that can be used by healthcare professionals with direct contact with people who smoke.
- Ask – at every patient contact, is the patient a current smoker, ex-smoker, or a non-smoker?
- Advise – the most successful way to stop smoking is through a combination of smoking cessation therapy medications and specialist support, all of which are available through the NHS.
- Act – build confidence, give information, refer and prescribe.
How should I assess a person who smokes?
- Assess the person's dependence on nicotine to help predict the severity of withdrawal symptoms they may experience.
- Ask about the two most important indicators of dependence and score the person's nicotine dependence depending on their answers:
- How many cigarettes they smoke per day — 0 points for 10 or less, 1 point for 11-20, 2 points for 21-30, and 3 points for 31 or more.
- How soon after waking they smoke their first cigarette — 3 points for within 5 minutes, 2 points for 6-30 minutes, 1 point for 31-60 minutes, and 0 points for after 60 minutes.
- The higher the score, the greater the level of nicotine dependence.
- Ask about previous quit attempts:
- How successful they were and if they tried any treatment.
- Whether they used any support, for example, through a smoking cessation service.
- The person's experiences of withdrawal symptoms and cravings.
- Ask about the person's medical history, and identify people in specific groups that may be at high risk of tobacco-related harm, including:
- People with mental health problems.
- People who misuse substances.
- People with a smoking-related illness (for example lung cancer).
- People with medical conditions exacerbated by smoking:
- Asthma.
- Cardiovascular disease.
- Chronic obstructive pulmonary disease.
- Type one diabetes mellitus.
- Women who are pregnant.
- Ask about current medication that may be affected by stopping smoking or starting smoking cessation treatment.
- For more information see the section on Drugs affected by stopping smoking.
- If available, measure the amount of carbon monoxide (CO) in expired air to provide a baseline.
- A person with a CO reading of 10 ppm or less is classed as a non-smoker.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014], a narrative review Supporting smoking cessation [Zwar, 2014], and information from the Specialist Pharmacy Service What are the clinically significant drug interactions with cigarette smoking? [SPS, 2020].
Assessing nicotine dependence
The National Centre for Smoking Cessation and Training (NCSCT) provide guidance about assessing nicotine dependence [NCSCT, 2014]:
- Cigarette consumption alone is not a good indicator of dependence, as it does not take into account the different ways in which and the intensity with which people smoke their cigarettes.
- The Fagerström test for cigarette dependence (FTCD) is a widely used quantitative measure of nicotine dependence.
- The full test consists of six questions, but the two most important indicators of dependence are considered to relate to how soon after waking a person desires to smoke and how many cigarettes are smoked each day.
- As self-reported smoking status can be unreliable, carbon monoxide (CO) breath testing should be carried out on all adult smokers. CO breath tests are quick, non-invasive, and provide a cost-effective validation of smoking status.
- Measuring CO levels prior to a smoking cessation attempt (as a basline), and at a four-week follow-up (as a validation) is recommended.
- A CO reading of 10 ppm or less is required to indicate a non-smoker.
Asking about previous quit attempts
- Quit attempts should draw on experiences from previous attempts to stop and should bear in mind factors that contributed to previous relapses [NCSCT, 2014].
Asking about current medication
- Most interactions between medicines and smoking are not clinically significant, but there are a small number of medicines that may need increased monitoring or dose adjustment when a person stops smoking [SPS, 2020].
- Medications of a particular importance include those with a narrow therapeutic index or where tobacco smoking induces cytochrome P450 enzymes to increase drug metabolism. These include, but are not limited to, aminophylline, theophylline, clozapine, erlotinib, olanzapine, and riociguat.
- Where useful, close monitoring of plasma levels, clinical progress, and adverse effects (occurrence and severity) is essential when patients change their smoking status.
Scenario: Adults
From age 18 years onwards.
How do I manage adults over 18 who want to stop smoking?
- Advise all people who smoke to stop.
- Offer referral to a local smoking cessation service, or inform the person how to access local NHS stop smoking services.
- People who are more dependent on nicotine should be especially encouraged to attend a smoking cessation service, as they are likely to need higher levels of support, a higher dose of medication, and several attempts at quitting.
- Inform the person that NHS stop smoking services offer evidence-based interventions, including:
- Behavioural support (individual and group, such as Allen Carr's Easyway seminars).
- Advice about stop smoking treatments (nicotine replacement therapy [NRT], cytisinicline, varenicline, and bupropion) and e-cigarettes.
- Can supply or arrange for a prescription, or give a voucher for, smoking cessation medicines.
- Note: Local or national incentives to reduce harm from smoking may mean that additional interventions are available through NHS stop smoking services.
- Explain that a combination of drug treatment and behavioural support has been shown to improve smoking cessation rates and may be the best option.
- For people who are unwilling or unable to be referred:
- Inform the person about sources of information and support for smoking cessation.
- Offer practical advice, encouragement, and support to help them stop smoking.
- Offer drug treatment to reduce withdrawal symptoms.
- Discuss the risks and benefits of drug treatment.
- Provide appropriate follow up.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and Standard treatment programme [NCSCT, 2019a]; and Cochrane systematic reviews Group behaviour therapy for smoking cessation [Stead, 2017], Individual behavioural counselling for smoking cessation [Lancaster, 2017], Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation [Hartmann-Boyce, 2019], and Strategies to improve smoking cessation rates in primary care [Lindson, 2021].
Counselling
- There is good evidence that individual smoking cessation counselling is more effective at helping people to stop smoking compared to receiving minimal support [Lancaster, 2017] or pharmacotherapy alone [Hartmann-Boyce, 2019].
- There is moderate certainty evidence that the provision of adjunctive counselling by a health professional other than the physician (practice nurse, counsellor, or smoking quitline) increases smoking cessation rates in primary care [Lindson, 2021].
- Group counselling has also been shown to be more effective than self-help and other less intensive forms of support [Stead, 2017].
- There is not sufficient evidence to conclude whether group or individual counselling is more effective.
- A 2019 Cochrane review pooled data from 65 trials (n=23,331 participants) and found that increasing the amount of behavioural support available to those attempting to stop smoking is likely to increase the chance of success by about 10% to 20% [Hartmann-Boyce, 2019].
Swap to Stop scheme
- In April 2023 the Department of Health and Social Care announced a new scheme which will provide e-cigarettes alongside behavioural support for people attempting to stop smoking [DHSC, 2023].
- The new measures included in this scheme were informed by an independent review which recommended that e-cigarettes should be offered as a substitute for smoking [OHID, 2022b].
What practical advice can I give adults over 18 years to help them to stop smoking?
- Advise the person:
- That the best way to stop smoking is to use a combination of behavioural support and medication.
- To set a quit date and commit to it.
- That the first few days after quitting are often the most difficult and they may experience withdrawal symptoms, but this usually starts to improve after the third or fourth day.
- Advise the person to concentrate on the benefits of stopping smoking during this period.
- Explain that cravings are powerful urges to smoke, often set off by:
- Stress.
- Seeing other people smoking.
- Becoming intoxicated.
- Inform the person that licenced stop smoking medicines help with withdrawal symptoms and cravings:
- Discuss stop smoking medicines.
- Discuss ways the person can manage cravings, for example, distraction strategies such as:
- Short bouts of moderate exercise, for example, brisk walking.
- Talking to a friend or family member.
- Keeping busy, for example, looking at the Smokefree app (www.nhs.uk), playing a game on a mobile phone, or drinking a glass of water.
- Changing the environment, for example, going into another room or going outside.
- Explain the importance of abrupt cessation and the ‘not-a-puff’ rule:
- This is where the person resolves to stop smoking altogether on or before a date — the target stop date. From this date, the person should not have a single puff on a cigarette.
- Advise that stopping smoking in one step (abrupt quitting) gives them the best chance of success.
- Explain that a first 'lapse', such as taking a puff from a cigarette, almost always leads to the person going back to regular smoking.
- Discuss how the person can get support to quit:
- Inform the person about sources of information and support, and give the contact details for these.
- Consider which family members and friends can support the person.
- If another person in the household smokes, consider stopping smoking together.
- Discuss how to avoid relapse.
- Advise that just smoking one cigarette could lead to the person returning to regular smoking (relapse).
- Help the person think of ways of managing stress, instead of smoking a cigarette.
- Advise the person to avoid being around people who smoke.
- Approximately three-quarters of people who relapse do so as they have been with other people who have been smoking.
- Advise the person to change their routine, and to avoid situations in which they would normally smoke until they can comfortably resist the urge to smoke. For example, recommend the person drinks no alcohol (or only has minimal amounts) in the first few weeks.
- Help the person work out ways to cope in situations in which they would normally smoke.
- Discuss any barriers to quitting the person may have, for example, stress or weight gain.
- Give examples of how the person can deal with stress, such as breathing and relaxation techniques.
- Explain that some, but not all, people put on weight after stopping smoking.
- Advise that even if the person puts on weight, they can always lose it in the future, and the risks of continuing to smoke are greater than those associated with gaining a small amount of weight.
- Give healthy lifestyle advice regarding exercise and healthy eating, including portion control www.nhs.uk.
- Advise the person to ensure they use their stop smoking medicines correctly, to minimise withdrawal symptoms and cravings.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and the 'Not a puff' rule [NCSCT, 2013], a narrative review Supporting smoking cessation [Zwar, 2014], the NHS Smokefree website www.nhs.uk, the NHS A-Z website www.nhs.uk, and the Action on Smoking and Health (ASH) briefing Stopping Smoking [ASH, 2020a].
Exercise
- The recommendation to advise people to use exercise to help with cravings is based on expert advice in a review article [Zwar, 2014].
- There is evidence that short bouts of moderate exercise; for example, brisk walking, can help with cravings and tobacco withdrawal symptoms although the optimal intensity of exercise to reduce these is not known [Roberts, 2012].
- However, a Cochrane review which examined whether exercise programmes improve quit rates in the longer-term (6 months or more) concluded there was insufficient evidence and that more high-quality research was needed [Ussher, 2019].
- Regular exercise may reduce weight gain associated with smoking cessation, particularly by 12 months post-cessation, however, more research is needed to clarify this [Hartmann-Boyce, 2021].
Family support
- There is some evidence that people who smoke that receive support from family and friends are more likely to quit, however, more research is needed to clarify this [Faseru, 2018].
Abrupt quitting
- A 2019 Cochrane systematic review combined data from up to 51 which collectively included 22,509 participants to investigate the effect of reducing smoking behaviours on long‐term smoking cessation [Lindson, 2019a].
- The results did not demonstrate that reducing smoking behaviour resulted in improved smoking cessation rates when compared with abrupt quitting practices.
Which sources of information and support should I direct adults who wish to stop smoking to?
- Inform people who wish to stop smoking how to access local NHS Stop Smoking Services:
- In England — the free Smokefree National Helpline on 0300 123 1044 or online www.nhs.uk. This offers support via a smartphone app, email programme, text messages, and a Facebook page.
- In Scotland — the free Smokeline on 0800 84 84 84 or online www.nhsinform.scot.
- In Wales — the free Help Me Quit Wales Helpline on 0800 085 2219 or online www.helpmequit.wales.
- In Northern Ireland — online https://www.stopsmokingni.info.
- Inform the person about other sources of information and support, such as:
- NHS A-Z www.nhs.uk.
- ASH (Action on Smoking and Health) ash.org.uk.
- QUIT, a national charity which provides telephone support www.quit.org.uk.
Basis for recommendation
The information on how to contact the local smoking cessation service is from the NHS A-Z website www.nhs.uk.
What drug treatment should I prescribe to an adult to help them stop smoking?
- If the person does not wish to, or cannot, attend a stop smoking service, advise them they are more likely to stop smoking using medication and offer to prescribe nicotine replacement therapy (NRT), cytisinicline, varenicline, or bupropion.
- Do not prescribe NRT with cytisinicline, varenicline, or bupropion.
- Do not prescribe cytisinicline or varenicline in combination with bupropion.
- Do not prescribe cytisinicline, varenicline, or bupropion to people under the age of 18.
- Do not prescribe cytisinicline to people aged 66 years or older.
- Inform the person that NRT, cytisinicline, varenicline, and bupropion have all been shown to be effective.
- Explain that there is no evidence that one form of NRT is more effective than another.
- The choice of treatment should be made on an individual basis, taking into account:
- The individual's previous experience with smoking cessation drugs.
- Their preference for treatment.
- Contraindications, cautions, possible interactions, and risk of adverse effects of the treatments.
- Prescribe sufficient NRT, cytisinicline, varenicline, or bupropion to last the person until 2 weeks after their stop date. Usually, this will be after 2 weeks of NRT, and 3-4 weeks of cytisinicline, varenicline, or bupropion.
- For people who would like to start NRT, discuss the available NRT formulations, the duration of treatment, and the possible adverse effects. Advise them:
- That patches are applied for 16 hours (and taken off overnight) or for 24 hours.
- That a 24-hour patch may be helpful if they smoke shortly after waking.
- That if they are using combination NRT, a nicotine patch will help with 'background' cravings, and a faster-acting product (such as lozenge or mouth spray) will help with 'breakthrough' urges to smoke.
- Not to have acidic drinks, such as coffee or fruit juice in the 15 minutes before using oral NRT.
- To start NRT on the quit date.
- For more information, see the prescribing information section for NRT.
- For people who would like to start cytisinicline — discuss the dose, duration of treatment, and the possible adverse effects.
- Explain that it needs to be started 5 days before the quit date.
- For more information, see the prescribing information section for cytisinicline.
- For people who would like to start varenicline — discuss the dose, duration of treatment, and the possible adverse effects.
- Explain that it needs to be started 7-14 days before the quit date.
- For more information, see the prescribing information section for varenicline.
- For people who would like to start bupropion — discuss the dose, duration of treatment, and the possible adverse effects.
- Explain that it needs to be started 7-14 days before the quit date.
- For more information, see the prescribing information section for bupropion.
- For people who wish to try to stop smoking using e-cigarettes, recommend they use a licensed stop smoking medicine instead.
- Explain that the combination of behavioural support from the local stop smoking service and licensed stop smoking medication is the most effective way of stopping smoking. There is less evidence available on the safety and effectiveness of e-cigarettes for stopping smoking.
- If the person prefers to use e-cigarettes, inform them that:
- Some people find e-cigarettes help them stop smoking.
- They can still receive support and advice from a smoking cessation clinic, and recommend that they do this to give themselves the best chance of quitting.
- Consider suggesting e-cigarettes as a way of stopping smoking to people who have tried unsuccessfully to stop smoking using other methods, using clinical judgement, and on an individual basis.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and Standard treatment programme [NCSCT, 2019a]; narrative reviews Supporting smoking cessation [Zwar, 2014] and Drugs for smoking cessation [Hartmann-Boyce, 2016]; a health technology assessment Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study [Dobbie, 2015]; the Scottish Intercollegiate Guidelines Network (SIGN) guideline Risk estimation and the prevention of cardiovascular disease [SIGN, 2017]; Cochrane systematic reviews Pharmacological interventions for smoking cessation: an overview and network meta‐analysis [Cahill, 2013], Nicotine receptor partial agonists for smoking cessation [Cahill, 2016], Combined pharmacotherapy and behavioural interventions for smoking cessation [Stead, 2016], Nicotine replacement therapy versus control for smoking cessation [Hartmann-Boyce, 2018], Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation [Hartmann-Boyce, 2019], Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation [Lindson, 2019b], Antidepressants for smoking cessation [Howes, 2020], and Electronic cigarettes for smoking cessation [Hartmann-Boyce, 2022]; the British national Formulary [BNF, 2023]; and what prodigy considers to be good clinical practice.
Effectiveness of stop smoking services
- The Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS) study concluded that Stop Smoking Services in England are effective in helping people stop smoking [Dobbie, 2015].
- The quit rate at 1 year was 8% and it is estimated that in 2012/13, 36,249 people were helped to become lifelong abstinent quitters (after taking into account a relapse rate of 35% after 1 year).
- Evidence from Cochrane reviews shows that combining medication and behavioural support increases the chance of quitting at 6 months compared with brief advice or support only [Stead, 2016], and that giving behavioural support (face-to-face or by telephone) to people using smoking cessation medication increases their chance of success by approximately 10 to 20% [Hartmann-Boyce, 2019].
Evidence for drug treatments
- NRT, varenicline, and bupropion are effective smoking cessation medications and are more effective than placebo at maintaining continuous abstinence from smoking after at least 6 months [Cahill, 2013; Cahill, 2016; Hartmann-Boyce, 2018; Howes, 2020].
- NRT increases a person's chance of stopping smoking by 50-60%, compared with placebo [Hartmann-Boyce, 2018].
- All forms of NRT are effective and there is no difference in efficacy between preparations.
- For patch dose comparisons, a Cochrane systematic review concludes that there is a moderate level of evidence that for 24-hour patches the 21 mg dose is more effective than the 14 mg, and for 16 hour patches the 25 mg dose is more effective than the 15 mg [Lindson, 2019b].
- A combination of NRT (in the form of a patch plus a fast-acting form of NRT) is more effective than using a single type of NRT [Cahill, 2013; Lindson, 2019b].
- Bupropion is as effective as NRT single therapy [Cahill, 2013; Howes, 2020], while varenicline is more effective than NRT single therapy, and as effective as combination NRT [Cahill, 2013].
- Standard dose varenicline increases the chances of abstinence from smoking at 6 months by 2-3 times compared with placebo [Cahill, 2016], and bupropion has been shown to increase the chances of stopping smoking by approximately 50% to 80% in the long-term (compared with placebo), but is less effective than varenicline [Howes, 2020]. However, bupropion use has been found to increase the risk of psychiatric adverse events, and people taking bupropion in clinical trials have been shown to be more likely to discontinue treatment compared with those receiving placebo [Howes, 2020].
Choice of treatment
- The therapeutic options of cytisincline, varenicline, combination short and long acting NRT, or nicotine-containing e-cigarettes in combination with behavioural support are the most effective at helping people stop smoking [NICE, 2025].
Electronic (e-) cigarettes
- The recommendations on e-cigarettes are based on the NICE guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025], Public Health England (PHE) reports [PHE, 2015b; PHE, 2018; PHE, 2021], a briefing on e-cigarettes Electronic cigarettes: a briefing for stop smoking services [NCSCT, 2016b], and the Royal College of General Practitioners (RCGP) position statement on the use of e-cigarettes [RCGP, 2016].
- E-cigarette products are the most popular aid used by people trying to quit smoking [PHE, 2021].
- Nationally representative survey data from 2020 indicated that 27.2% of people attempting to stop smoking used a vaping product in in the previous 12 months, compared with 15.5% who used NRT over-the-counter, 2.7% who used NRT on prescription, and 4.4% who used varenicline [PHE, 2021].
- E-cigarette use alone or in combination with licensed medication and behavioural support from a stop smoking service, appear to be helpful in the short-term [PHE, 2018; PHE, 2021; Hartmann-Boyce, 2022].
- A 2022 Cochrane review found [Hartmann-Boyce, 2022]:
- There was high certainty evidence that smoking cessation was higher in those randomised to nicotine containing e-cigarettes than in those randomised to NRT, with moderate certainty evidence that adverse event profiles were similar between the groups.
- There was high certainty evidence that smoking cessation was higher in those randomised to nicotine containing e-cigarettes than in those randomised to non-nicotine containing e-cigarettes.
- There was low certainty evidence that smoking cessation was higher in those randomised to nicotine containing e-cigarettes than in those randomised to behavioural support only or no support.
- The most commonly reported adverse effects were throat/mouth irritation, headache, cough, and nausea, which tended to resolve with continued use.
- A 2022 Cochrane review found [Hartmann-Boyce, 2022]:
- The combination of e-cigarette with support from stop smoking services is likely to optimise chances of stopping smoking when using an e-cigarette [PHE, 2018; PHE, 2021].
- PHE recommends that all services should offer support to smokers wishing to use an e-cigarette to stop smoking, however further randomised controlled trials are needed to assess the safety and effectiveness of e-cigarettes on smoking cessation or reduction.
How do I follow up adults who have started treatment to stop smoking?
- Initially, follow the person up after:
- 2 weeks of nicotine replacement therapy (NRT).
- 3-4 weeks of treatment with varenicline or bupropion.
- Measure the carbon monoxide (CO) level 4 weeks after quitting.
- A CO level of 10 ppm or less suggests the person is a non-smoker.
- Thereafter, use professional judgement about the number, timing, and frequency of appointments offered.
- Ask the person:
- How the quit attempt is going.
- Whether they are abstinent from smoking.
- About adverse effects from treatment — if the person is experiencing significant adverse effects, consider reducing the dose of the current treatment, or trying an alternative treatment (or formulation in the case of NRT).
- For people taking varenicline, consider reducing the dose to 500 micrograms twice daily.
- People taking varenicline or bupropion should stop treatment if they develop agitation, depressed mood, or suicidal thoughts.
- Withdrawal symptoms — if the person is having significant nicotine withdrawal symptoms, consider one of the following options:
- Increase the dose of the treatment (up to the maximum licensed dose that is tolerated).
- For people using NRT patches, combine with a rapid-release NRT product to relieve breakthrough symptoms, or if they experience withdrawal symptoms first thing in the morning, consider using a 24-hour patch.
- If the person has smoked cigarettes, but has not fully relapsed (returned to regular smoking), give encouragement to continue to try to stop smoking. Advise the person to:
- Commit to the 'not a puff' rule, and stay positive.
- Consider why they want to quit, and use this as motivation.
- Telephone the free NHS Smokefree helpline (0300 123 1014) to speak to a trained adviser if they feel tempted to restart smoking.
- Avoid places where people are smoking.
- If they experience cravings to smoke, wait 2 hours, and then decide if they are going to do so.
- Continue to take use NRT, varenicline, or bupropion, unless they have started smoking regularly.
- If the person has gone back to smoking regularly, advise them to:
- Stay positive, and set another quit date.
- Reassure them that most smokers make several quit attempts before they succeed.
- Review why they relapsed, and to think how they could avoid smoking in a similar situation in the future.
- Contact the local stop smoking service.
- If the person wants to quit, but cannot or does not want to stop in one step, ask them if they would like to try a harm reduction approach.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014], the British Medical Journal (BMJ) best practice guide Smoking cessation [BMJ Best Practice, 2023], expert opinion in narrative reviews Supporting smoking cessation [Zwar, 2014] and Drugs for smoking cessation [Hartmann-Boyce, 2016], the British National Formulary (BNF) [BNF, 2023], and the NHS website www.nhs.uk.
Follow-up frequency
- Follow-up visits with repeat clinical smoking cessation support have been shown to increase the likelihood of long-term abstinence and are especially useful in the first few weeks after quitting [Zwar, 2014; Bailey, 2018].
- An observational study from the US found that people who received clinical smoking cessation support at ≥75% of their healthcare visits had almost 3 times the odds of long-term smoking cessation compared to those with support documented at <25% of healthcare visits [Bailey, 2018].
Measuring CO levels
- CO monitoring is one of the evidence-based behavioural support techniques that can be highly motivating for people in their quit attempt [NCSCT, 2014].
Varenicline adverse effects
- There are concerns that varenicline causes adverse neuropsychiatric or cardiac events [Hartmann-Boyce, 2016].
- A Cochrane review found no significant difference in neuropsychiatric events in studies that compared varenicline with placebo [Cahill, 2013], and a large meta-analysis did not find that taking varenicline increased the risk of suicide or attempted suicide, suicidal ideation, or depression [Thomas, 2015]. A more recent Cochrane review concluded that although the evidence does not support a link between varenicline and depressed mood, agitation, or suicidal ideation or behaviour, people with past or current psychiatric disorders may be at slightly higher risk [Cahill, 2016].
- However, a large, randomised, double blind, placebo controlled study (Evaluating Adverse Events in a Global Smoking Cessation Study [EAGLES]) that compared the risk of serious neuropsychiatric events in people with or without a history of psychiatric disorder treated with varenicline, bupropion, NRT patch, or placebo suggested that the use of varenicline and bupropion in people with or without a previous psychiatric disorder was not associated with an increased risk of serious neuropsychiatric adverse events, compared with placebo or nicotine patch [Anthenelli, 2016].
- The manufacturer of varenicline advises that although smoking cessation can result in the emergence of serious neuropsychiatric symptoms, with or without varenicline treatment, should serious neuropsychiatric symptoms occur whilst using varenicline, it should be immediately discontinued and advice should be sought from a healthcare professional [ABPI, 2021f].
Bupropion adverse effects
- There have been concerns about people developing low mood, changes in behaviour, and suicidal thoughts while taking bupropion [Hartmann-Boyce, 2016].
- The results of the EAGLES study suggests that the use of bupropion in people with or without a previous psychiatric disorder is not associated with an increased risk of serious neuropsychiatric adverse events, compared with placebo or nicotine patch [Anthenelli, 2016].
- However, expert opinion in a narrative review recommends monitoring people taking bupropion for adverse psychological reactions [Hartmann-Boyce, 2016].
Scenario: Pregnant or breastfeeding
From age 12 years onwards (Female).
How do I manage pregnant or breastfeeding woman who want to stop smoking?
- Offer referral to a local smoking cessation service, or inform the woman how to access local NHS stop smoking services.
- People who are more dependent on nicotine should be especially encouraged to attend a smoking cessation service, as they are likely to need higher levels of support, a higher dose of medication, and several attempts at quitting.
- Give the woman the NHS Smokefree Helpline number (0300 123 1044), and advise her to phone if she would like to talk to someone while she is awaiting referral.
- Also refer pregnant women who have quit in the past 2 weeks and those with a carbon monoxide (CO) reading of 4 ppm or more.
- Light or infrequent smokers should also be referred, even if they register a lower reading – for example, 3 ppm.
- Inform the woman that NHS stop smoking services offer evidence-based interventions, including:
- Behavioural support (individual and group).
- Advice about stop smoking treatments.
- Can supply, arrange for a prescription, or give a voucher for stop smoking medicines.
- Note: Local or national incentives to reduce harm from smoking may mean that additional interventions are available through NHS Stop Smoking services.
- Explain that a combination of drug treatment and behavioural support has been shown to improve smoking cessation rates and may be the best option.
- For women who are unwilling or unable to be referred:
- Inform them about sources of information and support.
- Give the woman information about the risks of smoking to the unborn child, the risks of exposure to second-hand smoke for her and her baby, and the benefits of stopping smoking.
- Explain that the only way of making sure that the unborn baby is not at risk of harm from smoking is to stop completely, rather than reduce the number of cigarettes smoked.
- Offer practical advice, encouragement, and support to help them stop smoking.
- Consider offering nicotine replacement therapy (NRT) to reduce withdrawal symptoms.
- Provide appropriate follow up throughout pregnancy and after the baby is born.
- Ask whether the woman's partner or anyone in the household smokes.
- If they do, recommend they contact the NHS Stop Smoking Services.
- Give clear advice about the dangers of second-hand smoke to the pregnant woman and the baby before and after birth. For further information, see the section on the harms caused by smoking.
- Advise them not to smoke around the pregnant woman, mother, or baby, and that they should not smoke in the house or car.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014], Smoking Cessation: a briefing for midwifery staff [NCSCT, 2016a], and Standard treatment programme for pregnant women [NCSCT, 2019b]; the Office for Health Improvement and Disparities guidance Smoking and tobacco: applying all our health [OHID, 2022a]; and Cochrane systematic reviews Group behaviour therapy for smoking cessation [Stead, 2017], Individual behavioural counselling for smoking cessation [Lancaster, 2017], Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation [Hartmann-Boyce, 2019], Pharmacological interventions for promoting smoking cessation during pregnancy [Claire, 2020], and Strategies to improve smoking cessation rates in primary care [Lindson, 2021].
Counselling
- There is good evidence that individual smoking cessation counselling is more effective at helping people to stop smoking compared to receiving minimal support [Lancaster, 2017] or pharmacotherapy alone [Hartmann-Boyce, 2019].
- There is moderate certainty evidence that the provision of adjunctive counselling by a health professional other than the physician (practice nurse, counsellor, or smoking quitline) increases smoking cessation rates in primary care [Lindson, 2021].
- Group counselling has also been shown to be more effective than self-help and other less intensive forms of support [Stead, 2017].
- There is not sufficient evidence to conclude whether group or individual counselling is more effective.
- A 2019 Cochrane review pooled data from 65 trials (n=23,331 participants) and found that increasing the amount of behavioural support available to those attempting to stop smoking is likely to increase the chance of success by about 10% to 20% [Hartmann-Boyce, 2019].
Carbon monoxide (CO) testing
- Due to the heightened consequences of failing to identify pregnant women who smoke, an appropriate cut-off point for CO testing in pregnancy is lower than for the general adult population [NCSCT, 2014].
- All pregnant women with a CO reading of 4 parts per million (ppm) or above should be referred to stop smoking services [NICE, 2025].
NRT in pregnancy
- A 2020 Cochrane systematic review combined data from 9 studies, including 2336 pregnant women, and showed that NRT use may slightly improve smoking abstinence in pregnancy [Claire, 2020]. However, this evidence is considered of low certainty, as restricting the combined studies to only include randomised placebo-controllled trials did not show a clear benefit.
- A sub-group analysis of this data did not identify any difference in effectiveness for different types of NRT.
- The use of NRT in pregnancy was not found to increase the risk of adverse pregnancy or fetal outcomes including miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities, or neonatal death. One randomised placebo-controlled study found a higher rate of infant survival without developmental impairment at two years of age among the infants of those randomised to receive NRT.
Swap to Stop scheme
- In April 2023 the Department of Health and Social Care announced a new scheme which will provide financial incentive support for women attempting to stop smoking in pregnancy [DHSC, 2023].
- The new measures included in this scheme were informed by an independent review which recommended that financial incentives may help improve smoking cessation rates in pregnancy [OHID, 2022b].
What practical advice can I give pregnant or breastfeeding women to help them stop smoking?
- Provide verbal and written information on:
- The risks of smoking in pregnancy and the hazards of exposure to second-hand smoke for both mother and baby. For further information, see the section on the harms caused by smoking.
- The health benefits of stopping smoking to both mother and baby.
- Offer pregnant and breastfeeding women who smoke referral to an evidence-based smoking cessation service.
- Advise that the best way of stopping is with behavioural support through the local stop smoking service.
- Explain the service will also give information on NRT. This information can help the woman to decide whether to use this to stop smoking.
- Advise that there is a service locally that is effective, and that other women have found it useful.
- Give her the NHS smokefree Helpline number (0300 123 1044) and inform her that she can receive telephone support. Direct her to the NHS Smokefree and Start4life websites. For further information, see the section on sources of information and support.
- If the woman does not wish to be referred to a smoking cessation service:
- Inform her about sources of information and support for smoking cessation.
- Offer practical advice, encouragement, and support to help her stop smoking.
- Discuss the risks and benefits of NRT.
- Ask if her partner or anyone in the household smokes.
- If they do, recommend they contact the NHS Stop Smoking Services. For further information, see sources of information and support.
- Give clear advice about the dangers of second-hand smoke to the pregnant woman and the baby before and after birth. For further information, see the section on the harms caused by smoking.
- Advise them not to smoke around the pregnant woman, mother, or baby, and that they should not smoke in the house or car.
- Ask if she has any concerns about stopping smoking, and discuss these with her.
- Discuss why the woman wants to quit and the benefits of doing so.
- Advise her to write a list of these.
- Advise her to think of the above reasons during difficult times in her quit attempt to help her.
- Explain that:
- Many people who smoke keep smoking because they are dependent on nicotine, which is quickly sent to the brain each time they inhale cigarette smoke, rather than out of choice.
- Explain that most of the pleasure of smoking comes from relieving the symptoms of nicotine withdrawal.
- Describe withdrawal and recovery symptoms, including cravings.
- Explain that once a person stops smoking, their body begins a recovery process.
- During this time the person may feel restless, irritable, low in mood, frustrated, tired, have difficulty sleeping or concentrating, and have an increased appetite.
- Advise that the first few days after quitting are often the most difficult, and that this usually starts to improve after the third or fourth day.
- Advise the woman to concentrate on the benefits of stopping smoking during this period.
- Explain that cravings are powerful urges to smoke, often set off by:
- Stress
- Seeing other people smoking.
- Inform the woman that NRT can help with withdrawal symptoms and cravings.
- Discuss ways the woman can manage cravings, for example, distraction strategies such as:
- Short bouts of moderate exercise, for example, brisk walking.
- Talking to a friend or family member.
- Keeping busy, for example, looking at the Smokefree app (www.nhs.uk), playing a game on a mobile phone, or drinking a glass of water.
- Changing the environment, for example, going into another room or going outside.
- Explain the importance of abrupt cessation and the ‘not-a-puff’ rule.
- This is where the person resolves to stop smoking altogether on or before a date, the target stop date. From this date, the person should not have a single puff on a cigarette.
- Advise that stopping smoking in one step, 'abrupt quitting', gives the person the best chance of successfully stopping smoking.
- Explain that a first 'lapse', such as taking a puff from a cigarette, almost always leads to the person going back to regular smoking.
- Discuss how the woman can get support to quit:
- Inform the woman about sources of information and support and give the contact details for these.
- Consider which family members and friends can support the woman.
- If another person in the household smokes, consider stopping smoking together.
- Set a quit date and commit to this.
- Advise the woman to be positive and believe that she will succeed.
- Discuss how to avoid relapse.
- Help the woman think of ways of managing stress, instead of smoking a cigarette.
- Advise the woman to avoid being around people who smoke. Approximately 3/4 of people who relapse do so as they have been with other people who have been smoking.
- Advise the woman to change her routine, and to avoid situations in which she would normally smoke, until she can comfortably resist the urge to smoke.
- Help the woman work out ways to cope in situations in which she would normally smoke.
- Discuss any barriers to quitting the woman may have, for example, stress.
- Give examples of how the woman can deal with stress, such as breathing and relaxation techniques.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and the 'Not a puff' rule [NCSCT, 2013], a narrative review Supporting smoking cessation [Zwar, 2014], the NHS Smokefree website www.nhs.uk and A-Z website www.nhs.uk, and the Action on Smoking and Health (ASH) briefing Stopping Smoking [ASH, 2020a].
Exercise
- The recommendation to advise people to use exercise to help with cravings is based on expert advice in a review article [Zwar, 2014].
- There is evidence that short bouts of moderate exercise, for example, brisk walking, can help with cravings and tobacco withdrawal symptoms although the optimal intensity of exercise to reduce these is not known [Roberts, 2012].
- However, a Cochrane review which examined whether exercise programmes improve quit rates in the longer-term (6 months or more) concluded there was insufficient evidence and that more high-quality research was needed [Ussher, 2019].
- Regular exercise may reduce weight gain associated with smoking cessation, particularly by 12 months post-cessation, however, more research is needed to clarify this [Hartmann-Boyce, 2021].
Family support
- There is some evidence that people who smoke that receive support from family and friends are more likely to quit, however, more research is needed to clarify this [Faseru, 2018].
Abrupt quitting
- A 2019 Cochrane systematic review combined data from up to 51 which collectively included 22,509 participants to investigate the effect of reducing smoking behaviours on long‐term smoking cessation [Lindson, 2019a].
- The results did not demonstrate that reducing smoking behaviour resulted in improved smoking cessation rates when compared with abrupt quitting practices.
Providing advice about smoking in pregnancy
- Pregnant women can perceive various factors as barriers and enablers to smoking cessation during pregnancy [Barnett, 2019]:
- Perceived barriers to smoking cessation include a lack of understanding regarding the fetal risks with continued smoking in pregnancy, a lack of (or too much) pressure from healthcare professionals to encourage cessation, and insufficient support or access to practical help to aid cessation.
- Perceived enablers focus heavily around the health benefits that will be afforded to the fetus through smoking cessation, in addition to partner support.
Which sources of information and support should I direct pregnant or breastfeeding women who wish to stop smoking to?
- Inform pregnant and breastfeeding women who smoke how to access local NHS Stop Smoking Services:
- In England: call the free Smokefree National Helpline on 0300 123 1044 or online www.nhs.uk. This offers support via a smartphone app, email programme, text messages, and Facebook page.
- In Scotland: call the free Smokeline on 0800 84 84 84 or online www.nhsinform.scot.
- In Wales: call the free Help Me Quit Wales Helpline on 0800 085 2219 or online www.helpmequit.wales.
- In Northern Ireland: online www.want2stop.info.
- Via NHS A-Z www.nhs.uk.
- Inform the woman about other sources of information and support, such as:
- Start4life www.nhs.uk
- The Royal College of Obstetricians and Gynaecologists information leaflet, Smoking and Pregnancy, www.rcog.org.uk.
Basis for recommendation
The information on how to contact the local smoking cessation service is from the NHS A-Z website www.nhs.uk.
What drug treatment should I prescribe for a woman who is pregnant or breastfeeding to help her stop smoking?
- Preferably, women who are pregnant should stop smoking abruptly without using medication, such as nicotine replacement therapy (NRT), and they should be referred to the local smoking cessation service for behavioural support.
- If the woman does not wish to be referred to the local smoking cessation service:
- Consider offering to prescribe NRT— NRT can be considered in women who wish to use it and who have had a previous failed smoking cessation attempt without medication.
- Do not offer to prescribe varenicline or bupropion to pregnant or breastfeeding women.
- Discuss the risks and benefits of NRT.
- Inform the woman that NRT has been shown to be safe in pregnancy, may help aid smoking cessation in pregnancy, and that combination NRT (a patch plus a short-acting preparation) is considered the most effective treatment option.
- Explain that there is no evidence that one form of NRT is more effective than another.
- The choice of NRT should be made on an individual basis, taking into account the woman's:
- Previous experience with smoking cessation drugs.
- Preferences.
- Level of nicotine dependence.
- When prescribing NRT:
- Preferably prescribe intermittent dose forms (such as gum and lozenges) in preference to patches. Consider prescribing patches if the woman has significant pregnancy-related nausea and/or vomiting.
- Advise pregnant women to remove nicotine patches prior to going to bed.
- Advise not to have acidic drinks, such as coffee or fruit juice, in the 15 minutes before using oral NRT.
- Advise breastfeeding women to use NRT immediately after feeds, where possible.
- Prescribe sufficient NRT to last for 2 weeks after the stop date.
- For more information, see the prescribing information section for NRT.
- Preferably prescribe intermittent dose forms (such as gum and lozenges) in preference to patches. Consider prescribing patches if the woman has significant pregnancy-related nausea and/or vomiting.
- Reassure the woman that all nicotine products are licensed for use by pregnant and breastfeeding women.
- Explain that it is the tar and carbon monoxide in tobacco smoke that cause the most harm to the baby, and that these are not present in NRT.
- Explain that nicotine is present in small amounts in breastmilk, however, exposure to second-hand smoke is a much greater health risk to the baby.
- Encourage the woman to access behavioural support from the local smoking cessation clinic in order to increase her chance of successfully stopping smoking.
- If a pregnant woman asks about vaping or e-cigarettes, explain that:
- Vaping/electronic cigarettes are harmful to health compared to not smoking tobacco.
- It is not known if vaping is a safe way to stop smoking tobacco in pregnancy.
- Vapes do not contain some of the most toxic chemicals found in tobacco cigarettes and do appear to be less harmful to lung health in non-pregnant people for those who switch from smoking tobacco to vapes.
- However, vaping is not regulated for smoking cessation and they contain chemicals which are not present in tobacco. The impact of these chemicals on the fetus is not known.
- Recommend the use of NRT rather than e-cigarettes.
- If the woman has already chosen to use e-cigarettes to stop smoking or reduce the number of cigarettes smoked.
- Accept her decision.
- Provide encouragement to reduce reliance on vaping or smoking over time.
- Strongly caution against continuing to smoke tobacco whilst using vapes.
- Advise her that she can receive support from her smoking cessation service and offer referral.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014], Smoking Cessation: a briefing for midwifery staff [NCSCT, 2016a] and Standard treatment programme for pregnant women [NCSCT, 2019b]; the British Medical Journal (BMJ) best practice guide Smoking cessation [BMJ Best Practice, 2023]; narrative reviews Supporting smoking cessation [Zwar, 2014] and Drugs for smoking cessation [Hartmann-Boyce, 2016]; a health technology assessment Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study [Dobbie, 2015]; the Scottish Intercollegiate Guidelines Network (SIGN) guideline Risk estimation and the prevention of cardiovascular disease [SIGN, 2017]; Cochrane systematic reviews Combined pharmacotherapy and behavioural interventions for smoking cessation [Stead, 2016], Nicotine replacement therapy versus control for smoking cessation [Hartmann-Boyce, 2018], Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation [Hartmann-Boyce, 2019], and Pharmacological interventions for promoting smoking cessation during pregnancy [Claire, 2020]; the Smoking in Pregnancy Challenge Group (SPCG) guide Vaping before, during and after pregnancy [SIPCG, 2024]; the British national Formulary [BNF, 2023]; summary of product characteristics (SPCs) for nicotine replacement therapy (NRT) products [ABPI, 2021a; ABPI, 2021b; ABPI, 2021c; ABPI, 2021d; ABPI, 2021e; ABPI, 2022; ABPI, 2023a; ABPI, 2023b; BNF, 2023], and what CKS considers to be good clinical practice.
Effectiveness of stop smoking services
- The evaluating long-term outcomes of NHS stop smoking services (ELONS) study concluded that stop smoking services in England are effective in helping people stop smoking [Dobbie, 2015].
- The quit rate at 1 year was 8% and it is estimated that in 2012/13, 36,249 people were helped to become lifelong abstinent quitters (after taking into account a relapse rate of 35% after 1 year).
- Evidence from Cochrane reviews shows that combining medication and behavioural support increases the chance of quitting at 6 months compared with brief advice or support only [Stead, 2016] and that giving behavioural support (face-to-face or by telephone) to people using smoking cessation medication increases their chance of success [Stead, 2015].
Electronic (e-) cigarettes/vaping
- The recommendations on e-cigarette use in pregnancy are based on the NICE guideline NICE, 2025, the SIPGC guide [SIPCG, 2024], a randomised controlled trial [] and a systematic review [Ussher, 2024].
- NICE states that there is little evidence about the effectiveness or safety of using nicotine-containing e-cigarettes to help support smoking cessation in pregnancy and so did not make a recommendation on the use of e-cigarettes in pregnancy, but did make research recommendations NICE, 2025.
- The American College of Obstetricians and Gynaecologists (ACOG) 2020 Tobacco and Nicotine Cessation guidance [ACOG, 2020], advises that 'there is an incorrect perception that vaping represents a safer alternative to cigarette smoking because users are not inhaling tobacco combustion products, these products often contain nicotine or nicotine salts. Even if nicotine is not present in the e-liquid, exposure to flavourants and combustion products from the heating mechanism occurs. Nicotine crosses the placenta and intake in any form has considerable health risks with known adverse effects on fetal brain and lung tissue.'
- The authors therefore suggest that 'immediate discontinuation of e-cigarette and vaping products should be advised among all pregnant and postpartum women.'
- Research conducted on dual users of tobacco and e-cigarettes demonstrated significantly greater nicotine exposure and higher levels of other toxic biomarkers [Smith DM et al, 2021 Exposure to Nicotine and Toxicants Among Dual Users of Tobacco Cigarettes and E-Cigarettes: Population Assessment of Tobacco and Health (PATH) Study, 2013–2014] a further study on the same patient population confirmed that this increased exposure resulted in higher odds of incident respiratory symptoms [Reddy KP et al, 2021, Respiratory Symptom Incidence among People Using Electronic Cigarettes, Combustible Tobacco, or Both].
How do I follow up pregnant or breastfeeding women who wants to stop smoking?
- For women stopping smoking without NRT, review after 1 week and assess their quit attempt.
- For those remaining smoke-free and managing well, offer further encouragement. Review weekly for the first month, then monthly thereafter.
- For those who continue to smoke or have significant nicotine withdrawal symptoms, give advice and offer NRT. For further information, see the section on Drug treatment for pregnant or breastfeeding women.
- For women stopping smoking completely with NRT, review 1-2 weeks after the quit date, ask.
- How the quit attempt is going.
- Whether they are abstinent from smoking.
- About adverse effects from treatment — if the person is experiencing significant adverse effects, consider reducing the NRT dose or trying an alternative formulation.
- About withdrawal symptoms — if the person is having significant nicotine withdrawal symptoms, consider increasing the dose of the treatment (up to the maximum licensed dose that is tolerated).
- For women remaining smoke-free and managing well, review again one month after their quit date, and then monthly during pregnancy and after the baby has been born.
- Measure CO level 4 weeks after quitting.
- In pregnancy, a CO level of 4 ppm or lower suggests the person is a non-smoker.
- If the woman has smoked cigarettes, but has not fully relapsed (returned to regular smoking), advise her to:
- Commit to the 'not a puff' rule, and stay positive.
- Consider why she wants to quit and use this as motivation.
- Telephone the free NHS Smokefree helpline (0300 123 1014) to speak to a trained adviser if she feels tempted to restart smoking.
- Avoid places where people are smoking.
- If she has a craving to smoke, to wait 2 hours, and then decide if she is going to do so.
- Continue to use NRT unless she has started smoking regularly.
- If the woman has gone back to smoking regularly, advise her to:
- Stay positive and set another quit date.
- Reassure her that most people make several quit attempts before they succeed.
- Review why she relapsed, and to think how she could avoid smoking in a similar situation in the future
- Contact the local stop smoking service.
- If a pregnant woman has stopped smoking tobacco and is using e-cigarettes instead, encourage her to continue to abstain from tobacco, even if this means she will continue using e-cigarettes.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022] and the National Centre for Smoking Cessation and Training (NCSCT) Smoking Cessation: a briefing for midwifery staff [NCSCT, 2016a] and Standard treatment programme for pregnant women [NCSCT, 2019b].
- For women who successfully stopped smoking during pregnancy, postpartum relapse is a significant problem, and approximately 50% of women who have stopped smoking during pregnancy will relapse in the first 2 months after delivery [Ioakeimidis, 2019].
- Smoking cessation services should follow up pregnant women who have stopped smoking into the post-partum period [NCSCT, 2014].
- The recommendations on the advice to give pregnant or breastfeeding women who have relapsed or smoked some cigarettes but have not gone back to regular smoking during a quit attempt are extrapolated from information on the NHS A-Z website for adults trying to stop smoking www.nhs.uk
Carbon monoxide (CO) monitoring
- CO monitoring is one of the evidence-based behavioural support techniques that can be highly motivating for people in their quit attempt [NCSCT, 2014].
Biochemical validation
- Where resources allow, use urine or saliva cotinine levels to biochemically validate that the pregnant woman has stopped smoking, on the date set for stopping and 4 weeks after. Urine/saliva cotinine concentration is considered to be a more accurate measure of continued tobacco smoking as they can detect exposure over the past few days rather than hours . NRT use can the raise urine/saliva cotinine concentration [NICE, 2025].
Scenario: 12-17 years
From age 12 years to 17 years.
How do I manage young people aged from 12-17 who want to stop smoking?
- Advise all young people who smoke to stop.
- Offer referral to a local smoking cessation service, or inform them how to access local NHS Stop Smoking Services.
- People who are more dependent on nicotine should be especially encouraged to attend a smoking cessation service, as they are likely to need higher levels of support, a higher dose of medication, and several attempts at quitting.
- Give them the NHS Smokefree Helpline number (0300 123 1044), and advise them to phone if they would like to talk to someone while awaiting referral.
- Inform them that NHS Stop Smoking services offer evidence-based interventions, including:
- Behavioural support (individual and group).
- Advice about nicotine replacement therapy (NRT).
- Can supply, arrange for a prescription, or give a voucher for stop smoking medicines.
- Note: Local or national incentives to reduce harm from smoking may mean that additional interventions are available through NHS Stop Smoking services.
- Explain that a combination of drug treatment and behavioural support has been shown to improve smoking cessation rates and may be the best option.
- For people who are unwilling or unable to be referred:
- Inform the person about sources of information and support for smoking cessation.
- Offer practical advice, encouragement, and support to help them stop smoking.
- Discuss the risks and benefits of NRT.
- Use professional judgement when deciding whether to offer NRT to young people.
- Do not prescribe varenicline or bupropion to people aged under 18 years.
- If the person is going to use NRT, explain they are more likely to stop smoking if they also use behavioural support from the stop smoking service, than NRT alone. Encourage them to take up referral to the local smoking cessation service.
- Follow up the young person appropriately.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and Standard treatment programme [NCSCT, 2019a]; and Cochrane systematic reviews Group behaviour therapy for smoking cessation [Stead, 2017], Individual behavioural counselling for smoking cessation [Lancaster, 2017], Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation [Hartmann-Boyce, 2019], and Strategies to improve smoking cessation rates in primary care [Lindson, 2021].
Counselling
- There is good evidence that individual smoking cessation counselling is more effective at helping people to stop smoking compared to receiving minimal support [Lancaster, 2017] or pharmacotherapy alone [Hartmann-Boyce, 2019].
- There is moderate certainty evidence that the provision of adjunctive counselling by a health professional other than the physician (practice nurse, counsellor, or smoking quitline) increases smoking cessation rates in primary care [Lindson, 2021].
- Group counselling has also been shown to be more effective than self-help and other less intensive forms of support [Stead, 2017].
- There is not sufficient evidence to conclude whether group or individual counselling is more effective.
- A 2019 Cochrane review pooled data from 65 trials (n=23,331 participants) and found that increasing the amount of behavioural support available to those attempting to stop smoking is likely to increase the chance of success by about 10% to 20% [Hartmann-Boyce, 2019].
Young people and smoking
- Young people who experiment with smoking can quickly become addicted to nicotine and can show signs of addiction within four weeks of starting to smoke, and before they start smoking every day [ASH, 2019].
- During periods of abstinence, young people experience withdrawal symptoms similar to the kind experienced by adult smokers [ASH, 2019].
What practical advice can I give people aged 12-17 years to help them to stop smoking?
- For information on advice to give young people aged over 12 years who want to stop smoking, see the section on advice in the Scenario: Adults.
What drug treatment should I prescribe to young people aged 12-17 years to help them stop smoking?
- If the young person does not wish to be referred to the local smoking cessation service:
- Offer to prescribe nicotine replacement therapy (NRT) — do not prescribe varenicline or bupropion to people aged under 18 years.
- Inform them that NRT has been shown to be effective, and that combination NRT (a patch plus a short-acting preparation) is the most effective treatment.
- Explain that there is no evidence that one form of NRT is more effective than another.
- Discuss the risks and benefits of NRT.
- Elicit and address any concerns the person may have about NRT.
- Discuss the available NRT formulations, the duration of treatment, and the possible adverse effects. The choice of NRT formulation should be made on an individual basis, taking into account:
- Previous experience with smoking cessation drugs.
- Preferences.
- Level of nicotine dependence.
- Advise them:
- That patches are applied for 16 hours (and taken off overnight) or for 24 hours.
- That a 24-hour patch may be helpful if they smoke shortly after waking.
- That if they are using combination NRT, a nicotine patch will help with 'background' cravings and a faster-acting product (such as lozenge or mouth spray) will help with 'breakthrough' urges to smoke.
- Not to have acidic drinks, such as coffee or fruit juice, in the 15 minutes before using oral NRT.
- To start NRT on the quit date.
- That stopping smoking in one stop ('abrupt quitting') gives the best chance of a person successfully stopping smoking.
- For more information, see the prescribing information section for NRT.
- Prescribe sufficient NRT to last for 2 weeks after the stop date.
- If the young person asks about using e-cigarettes, explain that e-cigarettes cannot be sold to under-18s, and it is illegal for an adult to buy e-cigarettes for someone under 18.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and Standard treatment programme [NCSCT, 2019a]; narrative reviews Supporting smoking cessation [Zwar, 2014] and Drugs for smoking cessation [Hartmann-Boyce, 2016]; a health technology assessment Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study [Dobbie, 2015]; the Scottish Intercollegiate Guidelines Network (SIGN) guideline Risk estimation and the prevention of cardiovascular disease [SIGN, 2017]; Cochrane systematic reviews Pharmacological interventions for smoking cessation: an overview and network meta‐analysis [Cahill, 2013], Combined pharmacotherapy and behavioural interventions for smoking cessation [Stead, 2016], Nicotine replacement therapy versus control for smoking cessation [Hartmann-Boyce, 2018], and Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation [Hartmann-Boyce, 2019]; the British national Formulary for Children [BNFC, 2023]; and what prodigy considers to be good clinical practice.
Effectiveness of stop smoking services
- The Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS) study concluded that Stop Smoking Services in England are effective in helping people stop smoking [Dobbie, 2015].
- The quit rate at 1 year was 8% and it is estimated that in 2012/13, 36,249 people were helped to become lifelong abstinent quitters (after taking into account a relapse rate of 35% after 1 year).
- Evidence from Cochrane reviews shows that combining medication and behavioural support increases the chance of quitting at 6 months compared with brief advice or support only [Stead, 2016], and that giving behavioural support (face-to-face or by telephone) to people using smoking cessation medication increases their chance of success by approximately 10 to 20% [Hartmann-Boyce, 2019].
Other stop smoking medicines
- Bupropion and varenicline are not recommended because they are not licensed for use in children younger than 18 years of age [BNFC, 2023].
- NRT increases a person's chance of stopping smoking by 50-60%, compared with placebo [Hartmann-Boyce, 2018].
- All forms of NRT are effective, and there is no difference in efficacy between preparations.
- A combination of NRT (in the form of a patch plus a fast-acting form of NRT) is more effective than using a single type of NRT [Cahill, 2013].
Electronic (e-) cigarettes
- Across the UK there is a minimum age of sale of 18 for e-cigarettes and adults are prohibited from purchasing these products on behalf of someone under the age of 18 [PHE, 2021].
How should I follow up young people aged 12-17 years who have started treatment to stop smoking?
- Initially, follow the person up after 2 weeks of nicotine replacement therapy (NRT).
- Measure the carbon monoxide (CO) level 4 weeks after quitting.
- A CO level of 10 ppm or less suggests the person is a non-smoker.
- Thereafter, use professional judgement about the number, timing, and frequency of appointments offered.
- Ask the person:
- How the quit attempt is going.
- Whether they are abstinent from smoking.
- About adverse effects from treatment — if the person is experiencing significant adverse effects, consider reducing the dose or trying an alternative formulation of NRT.
- Withdrawal symptoms — if the person is having significant nicotine withdrawal symptoms, consider one of the following options:
- Increase the dose of the treatment (up to the maximum licensed dose that is tolerated).
- For people using NRT patches, combine with a rapid-release NRT product to relieve breakthrough symptoms, or if they experience withdrawal symptoms first thing in the morning, consider using a 24-hour patch.
- If the young person has smoked cigarettes, but has not fully relapsed (returned to regular smoking), give encouragement to continue to try to stop smoking. Advise the person to:
- Commit to the 'not a puff' rule and stay positive.
- Consider why they want to quit and use this as motivation.
- Telephone the free NHS Smokefree helpline (0300 123 1014) to speak to a trained adviser if they feel tempted to restart smoking.
- Avoid places where people are smoking.
- If they experience cravings to smoke, wait 2 hours, and then decide if they are going to do so.
- Continue to take use NRT unless they have started smoking regularly.
- If the person has gone back to smoking regularly, advise them to:
- Stay positive and set another quit date.
- Reassure them that most smokers make several quit attempts before they succeed.
- Review why they relapsed and to think how they could avoid smoking in a similar situation in the future.
- Contact the local stop smoking service.
- If the person wants to quit, but cannot or does not want to stop in one step, ask them if they would like to try a harm reduction approach.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022], the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014], the British Medical Journal (BMJ) best practice guide Smoking cessation [BMJ Best Practice, 2023], expert opinion in narrative reviews Supporting smoking cessation [Zwar, 2014] and Drugs for smoking cessation [Hartmann-Boyce, 2016], the British National Formulary for Children [BNFC, 2023], and the NHS website www.nhs.uk.
Follow-up frequency
- Follow-up visits with repeat clinical smoking cessation support have been shown to increase the likelihood of long-term abstinence and are especially useful in the first few weeks after quitting [Zwar, 2014; Bailey, 2018].
- An observational study from the US found that people who received clinical smoking cessation support at ≥75% of their healthcare visits had almost 3 times the odds of long-term smoking cessation compared to those with support documented at <25% of healthcare visits [Bailey, 2018].
Measuring carbon monoxide levels
- CO monitoring is one of the evidence-based behavioural support techniques that can be highly motivating for people in their quit attempt [NCSCT, 2014].
Scenario: Harm reduction
From age 12 years onwards.
How do I manage an adult who is not ready to stop smoking?
- For people who are unwilling or not ready to stop smoking:
- Ensure they understand the health risks associated with smoking.
- Encourage them to seek help to quit smoking completely in the future.
- Offer a harm-reduction approach to smoking.
- Stopping smoking, but continuing to use nicotine replacement therapy (NRT).
- Cutting down before stopping smoking, with or without NRT.
- Smoking reduction, with or without NRT.
- Temporary abstinence from smoking, with or without NRT.
- NRT may be used as long as necessary to prevent relapse.
- Record the fact that they smoke and at every opportunity ask them about it again in a way that is sensitive to their preferences and needs.
- Advise them that:
- It is better to use NRT and decrease how much they smoke, than to keep on smoking as they are currently.
- NRT preparations are a safe and effective way of cutting down on how much they smoke.
- Their use improves their chance of stopping smoking in the long-term and helps reduce compensatory smoking (inhaling more deeply when fewer cigarettes are smoked).
- If the person agrees to try a harm reduction approach, ask about:
- Their reasons for smoking.
- Their smoking triggers.
- Their smoking behaviour.
- Previous attempts to quit smoking.
- Their health and social circumstances.
- Use shared decision-making to decide which harm-reduction approach is most suitable for the person.
- Offer referral to a smoking cessation service if more intensive support is needed or if the person prefers this.
- For people who would like to start NRT, discuss the available formulations and the possible adverse effects. The choice of treatment should be made on an individual basis, taking into account:
- The individual's previous experience with smoking cessation drugs.
- Their preference for treatment.
- Level of nicotine dependence.
- Advise them:
- That long-acting products, such as patches, deliver a steadier supply of nicotine, whereas fast-acting products help with cravings.
- That patches are applied for 16 hours (and taken off overnight) or for 24 hours.
- That a 24-hour patch may be helpful if they smoke shortly after waking.
- Using a combination of NRT products is more effective, especially for people who are highly dependent on nicotine (for example a patch with a short acting form such as gum or lozenge).
- That if they are using combination NRT, a nicotine patch will help with 'background' cravings, and a faster-acting product (such as lozenge or mouth spray) will help with 'breakthrough' urges to smoke.
- Ensure the person knows how to maintain a nicotine dose high enough to control cravings and therefore avoid compensatory smoking and relapse.
- Advise the person to use a licensed nicotine-containing product, such as a lozenge or piece of gum instead of each cigarette, and to use this before the time they would usually smoke the cigarette (as the nicotine release from NRT products is slower than from cigarettes).
- Advise to not have acidic drinks, such as coffee or fruit juice, in the 15 minutes before using oral NRT.
- For more information, see the prescribing information section for NRT.
- Prescribe NRT to the person, or advise them where they can buy it.
- Offer support — use the information gathered when assessing the person's smoking behaviour and nicotine dependency to set goals and develop reduction strategies (such as lengthening the time between cigarettes, smoking the first cigarette later in the day, or choosing times during the day when they will not smoke).
- Help people who are cutting down before stopping to decide upon a quit date, and how they are going to cut down in preparation for this — the quit date should usually be within 6 weeks of starting support.
- Help people who wish to cut down on smoking, without actually stopping, decide how they are going to do this and plan a date to have achieved their goal.
- Arrange follow up to review and support the person — use professional judgement to decide the timing and frequency of follow up appointments.
- If the person has successfully cut down on their smoking, explore how motivated they are to continue to smoke at that level, or to reduce this further or stop smoking.
- If the person has managed to abstain temporarily, encourage them to think of other times or situations in which they could abstain.
- Ask whether daily activities, such as climbing a flight of stairs, have become easier. Use this information to discuss the benefits of cutting down their smoking, and whether the person could reduce their smoking further or stop.
- If the person has not achieved their goals, support them to try again. Discuss whether to make changes to their approach, for example, trying a different licenced nicotine-containing product, or a combination of these.
- If available, measure exhaled CO level to monitor the person's progress and help encourage them.
- If the person wishes to use e-cigarettes in their harm-reduction approach, recommend they use a licenced nicotine-containing product instead.
- If a young person asks about using e-cigarettes, explain that e-cigarettes cannot be sold to under-18s, and it is illegal for an adult to buy e-cigarettes for someone under 18. Young people should use a licensed nicotine-containing product when attempting a harm reduction approach.
- If the person prefers to use e-cigarettes, inform them that:
- E-cigarettes can be used to deliver some of the nicotine that the person would have otherwise received from regularly smoking cigarettes.
- Some people find e-cigarettes can help them stop smoking or cut down the number of cigarettes they smoke or with temporary abstinence.
- E-cigarettes cannot currently be prescribed or supplied by NHS smoking cessation clinics. However, the majority of local authority smoking cessation clinics do provide them as part of a harm reduction approach.
- The quality and safety of e-cigarettes cannot be assured (for example the ingredients, or how much nicotine they contain).
- Although e-cigarettes are not risk free, using these is thought to be around 95% less harmful to health than smoking. However, the long-term risks are unknown, but these are likely to be much smaller than the risks of smoking.
- They can still receive support and advice from a smoking cessation clinic, and recommend that they do this to give themselves the best chance of quitting.
Basis for recommendation
These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) guidelines Local stop smoking services: service and delivery guidance [NCSCT, 2014] and Electronic cigarettes: A briefing for stop smoking services [NCSCT, 2016b]; the Public Health England (PHE) report Vaping in England: evidence update February 2021 [PHE, 2021]; the Royal College of Physicians (RCP) report Nicotine without smoke: tobacco harm reduction [RCP, 2016]; the Royal College of General Practitioners (RCGP) position statement on the use of e-cigarettes [RCGP, 2016]; and Cochrane systematic reviews Pharmacological interventions for smoking cessation: an overview and network meta‐analysis [Cahill, 2013], Combined pharmacotherapy and behavioural interventions for smoking cessation [Stead, 2016], and Nicotine replacement therapy versus control for smoking cessation [Hartmann-Boyce, 2018].
E-cigarettes and harm reduction
- The recommendation that e-cigarettes can be used in harm reduction is supported by expert opinion [NCSCT, 2014].
- However, the NCSCT states that evidence of effectiveness is still emerging.
- The NCSCT briefing on e-cigarettes states that some people find these helpful for cutting down on smoking or for temporary abstinence from smoking [NCSCT, 2016b].
- NICE recommends the use of licensed NRT for harm reduction. As e-cigarettes are not regulated by the MHRA, there is a lack of information on their effectiveness, safety and quality, NICE does not recommend the use of e-cigarettes as a harm reduction approach. However, it does state that e-cigarettes are likely to be less harmful than smoking [NICE, 2025].
- The RCP report also states that as the quality of e-cigarettes varies depending upon the manufacturing standards of each brand, it is likely that NRT is safer than some e-cigarettes [RCP, 2016].
- There is evidence from observational studies, that people who smoke cigarettes and use e-cigarettes are more likely to try to stop smoking than people who only smoke tobacco [PHE, 2021]. However, it is not known whether they are more likely to be successful.
- The PHE report, Vaping in England: evidence update February 2021, concludes that encouraging smokers who cannot or do not want to stop smoking to change to using e-cigarettes could help decrease disease and deaths due to smoking [PHE, 2021].
- CKS recommends that healthcare professionals advise people to use NRT rather than e-cigarettes for harm reduction.
- However, if the person prefers to use e-cigarettes, CKS advises giving the person similar advice to people who use e-cigarettes in smoking cessation.
- Use of e-cigarettes cannot be recommended as a harm reduction method for young people as, across the UK, there is a minimum age of sale of 18 for vaping products and adults are prohibited from purchasing vaping products on behalf of someone under the age of 18 [PHE, 2021].
Prescribing information
Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information see the electronic Medicines Compendium (eMC), or the British National Formulary (BNF).
Nicotine replacement therapy (NRT)
Available formulations of NRT
- Nicotine replacement therapy (NRT) is available in a choice of formats, including:
- Gum — nicotine is absorbed through the buccal mucosa, with peak plasma concentrations occurring after 20–30 minutes. Available in different flavours and strengths, one piece of gum lasts for about 30 minutes. Gum is difficult to use with dentures and may damage them.
- Inhalator — nicotine is absorbed through the buccal mucosa. When used like a cigarette, on average it delivers 1 mg in 80 puffs, and 2 mg of nicotine is released during 20 minutes of intensive use. Each 15 mg cartridge can be used for approximately eight 5-minute sessions, with each cartridge lasting for approximately 40 minutes of intense use.
- Lozenge — nicotine is absorbed through the buccal mucosa. Available in different strengths and flavours, lozenges dissolve completely in 10–20 minutes. The lozenge should not be chewed or swallowed.
- Nasal spray — nicotine is rapidly absorbed through the nasal mucosa, delivering peak plasma levels within 10–15 minutes.
- Oral spray — nicotine is rapidly absorbed through the buccal mucosa, delivering peak plasma levels within 13 minutes.
- Sublingual tablet — nicotine is absorbed through the buccal mucosa.
- Transdermal patch — nicotine is absorbed through the skin. Available in 16-hour and 24-hour preparations, in a range of strengths, peak plasma levels are reached within 8–10 hours.
- The 24-hour preparation may be suitable for people who experience strong cravings for cigarettes on waking.
- Some patches are translucent and may be preferred by some people as they are more discrete.
- See the section on Dose and duration of NRT for details on how to prescribe and use each product.
[ABPI, 2021a; ABPI, 2021b; ABPI, 2021c; ABPI, 2021d; ABPI, 2021e; ABPI, 2022; ABPI, 2023a; ABPI, 2023b; BNF, 2023]
Dose and duration
- Prescribe nicotine replacement therapy (NRT) by brand name, as dosage instructions vary between brands of NRT.
- For information on the dose, duration, and usage instructions for specific brands of NRT products, see the appropriate Summary of Product Characteristics (SPC) in the electronic Medicines Compendium.
- Smokers must use sufficient NRT in order to achieve good success rates.
- As insufficient use is the main problem with intermittent (non-patch) formulations of NRT, some expert reviewers advise regular hourly use with topping-up as needed for all intermittent formulation products.
- The duration of treatment with NRT is 8–12 weeks (depending on which form of NRT is used and which dose is initiated), followed by a gradual reduction in dose.
- Use of NRT for longer than nine months should be under the direction of a healthcare professional.
- For children over the age of 12 years, treatment should be limited to 12 weeks.
- Treatment with NRT can be stopped abruptly or tapered gradually — abruptly stopping NRT does not seem to reduce its effectiveness.
- Higher doses of nicotine replacement therapy (NRT) may be more effective in people who are more highly dependent on cigarettes, and more dependent smokers may need to use NRT for longer than 3 months — if treatment is stopped too soon these people might relapse.
Contraindications and cautions
- Prescribe nicotine replacement therapy (NRT) with caution to people with:
- Diabetes mellitus (users should be encouraged to monitor blood glucose closely when initiating treatment).
- Gastrointestinal disease.
- Phaeochromocytoma.
- Moderate to severe hepatic impairment.
- Severe renal impairment.
- Uncontrolled hyperthyroidism.
- History of epilepsy.
- Also prescribe NRT with caution to haemodynamically unstable people hospitalised with:
- Cerebrovascular accident.
- Myocardial infarction.
- Severe arrhythmias.
- Specific NRT formats should also be prescribed with caution in certain circumstances:
- Inhalator — people with chronic throat disease and bronchospastic disease.
- Gum — people with dentures.
- Nasal spray — people with asthma.
[ABPI, 2021a; ABPI, 2021b; ABPI, 2021c; ABPI, 2021d; ABPI, 2021e; ABPI, 2022; ABPI, 2023a; ABPI, 2023b; BNF, 2023]
Adverse effects
- Common adverse effects of nicotine replacement therapy (NRT) include:
- Headaches and dizziness.
- Nausea and vomiting.
- Rash and urticaria.
- Hyperhidrosis.
- Palpitations.
- Uncommon adverse effects of NRT include:
- Dyspnoea.
- Flushing and hypertension.
- Malaise.
- Myalgia.
- Paraesthesia.
- Rare adverse effects of NRT include:
- Anaphylaxis.
- Angioedema and erythema.
- Atrial fibrillation.
- Gastrointestinal discomfort.
- Other common adverse effects for specific formulations include:
- Gum — throat irritation, increased salivation, dry mouth, and jaw pain.
- Inhalator — cough and irritation of the mouth and throat (in about 40% of people), nasal congestion, and altered taste.
- Lozenge — irritation of the mouth and throat, jaw pain, increased salivation, and dysphagia.
- Nasal spray — nasal irritation, running nose, epistaxis, sneezing, and watery eyes.
- Oral spray — taste disturbance, mouth ulcers, gingival bleeding, increased salivation, dry mouth, toothache, partial loss of sensation in the throat, and eye disorders.
- Patch:
- Mild local reactions such as urticaria, itching, and redness at the patch application site(s). In some people the skin reaction may become more severe (blistering and burning sensation) or be more widespread.
- Sleep disturbances; for example, vivid dreams and insomnia, have also been reported with patches. Removing the patches before bed (that is changing from a 24-hour patch to a 16-hour patch) may help.
- Sublingual tablet — sore mouth or throat, dry mouth, burning sensation in the mouth, and rhinitis.
- Adverse effects may occur at initiation of treatment with NRT, especially in people using high-strength preparations. However, it is possible to confuse adverse effects of NRT with nicotine withdrawal symptoms (for example malaise, headache, sleep disturbance, and irritability).
- Adverse effects are generally mild and are unlikely to lead to discontinuation of treatment, but people may prefer to try an alternative formulation (for example changing from a 24-hour patch to a 16-hour patch if sleep is disturbed).
[ABPI, 2021a; ABPI, 2021b; ABPI, 2021c; ABPI, 2021d; ABPI, 2021e; ABPI, 2022; ABPI, 2023a; ABPI, 2023b; BNF, 2023]
Drug interactions
- There are no known clinically relevant drug-drug interactions with nicotine replacement therapy (NRT).
- Acidic beverages, such as coffee or fruit juice, may decrease the absorption of oral nicotine and should be avoided for 15 minutes before the use of oral NRT.
[ABPI, 2021a; ABPI, 2021b; ABPI, 2021c; ABPI, 2021d; ABPI, 2021e; ABPI, 2022; ABPI, 2023a; ABPI, 2023b; BNF, 2023]
Pregnancy and breastfeeding
Pregnancy
- Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby. NRT should only be used if smoking cessation without NRT fails.
- Intermittent therapy is preferred, but patches may be necessary.
- Where patches are used, these should be removed prior to going to bed.
Breastfeeding
- Small amounts of nicotine are excreted in breastmilk, however, this is less hazardous than second-hand smoke.
- Intermittent therapy is preferred in women who are breastfeeding.
[LactMed, 2020; RCOG, 2020; ABPI, 2021a; ABPI, 2021b; ABPI, 2021c; ABPI, 2021d; ABPI, 2021e; ABPI, 2022; ABPI, 2023a; ABPI, 2023b; BNF, 2023]
Bupropion
Mode of action of bupropion
- Bupropion is a relatively weak but selective dopamine and noradrenaline reuptake inhibitor. Although the exact mechanism by which it aids smoking cessation is unclear, it is presumed to work directly on the brain pathways involved in addiction and withdrawal.
Dose
- Bupropion should be started while the person is still smoking.
- Advise the person to stop smoking 7–14 days after starting bupropion.
- The dose of bupropion is 150 mg once a day for 6 days, increasing to 150 mg twice a day (doses at least 8 hours apart) for a total of 7–9 weeks.
- If no effect is seen after 7 weeks, discontinue treatment with bupropion.
- The lower dose of 150 mg once a day should be continued if the person:
- Is elderly.
- Has mild to moderate hepatic impairment.
- Has renal impairment (estimated glomerular filtration [eGFR] rate less than 50 mL/min).
- Has risk factors for seizures.
- After the course is completed discontinuation reactions are unlikely and bupropion can be stopped without tapering the dose.
- However, if required, a tapering-off period can be considered.
Contraindications and cautions
- Do not prescribe bupropion to people aged under 18 years, or people with:
- A current seizure disorder, or a history of seizures.
- Acute alcohol or benzodiazepine withdrawal.
- A central nervous system (CNS) tumour.
- A current or previous diagnosis of bulimia or anorexia nervosa.
- A history of bipolar disorder.
- Severe hepatic cirrhosis.
- Prescribe bupropion with caution to the elderly and to people with:
- A predisposition to seizures. Risk factors include:
- Alcohol abuse.
- A history of head trauma.
- Diabetes.
- Taking other drugs which lower the seizure threshold (for example antipsychotics).
- Use of stimulants or anorectic products.
- Hepatic impairment.
- Renal impairment.
- A hereditary risk of Brugada syndrome, which is a rare hereditary disease of cardiac sodium channel with specific ECG changes (ST segment elevation and T wave abnormalities in the right precordial leads). Buproprion may unmask Brugada syndrome which can lead to cardiac arrest and/or sudden death.
- A predisposition to seizures. Risk factors include:
Adverse effects
- Adverse effects of bupropion include:
- Metabolism and nutrition — anorexia (uncommon).
- Rarely: blood glucose disturbances and hyponatraemia.
- Psychiatric — insomnia (very common), depression, agitation, anxiety (common), and confusion (uncommon).
- Rarely or very rarely: irritability, hostility, hallucinations, depersonalisation, abnormal dreams including nightmares, delusions, aggression, and paranoia.
- Nervous system — tremor, concentration disturbance, headache, dizziness, and taste disorders (common).
- Rarely: seizures, dystonia, ataxia, Parkinsonism, incoordination, memory impairment, paraesthesia, and syncope.
- Metabolism and nutrition — anorexia (uncommon).
- Other common adverse effects include:
- Dry mouth, nausea, vomiting, abdominal pain, and constipation.
- Fever.
- Hypersensitivity reactions (for example urticaria).
- Rash, pruritus, and sweating.
- Other rare adverse effects include:
- Angioedema, dyspnoea/bronchospasm, and anaphylactic shock.
- Arthralgia and myalgia.
- Erythema multiforme and Stevens-Johnson syndrome.
- Palpitations.
- Urinary frequency/retention.
- Vasodilation and postural hypotension.
- Alopecia.
- Other adverse events where the incidence is unknown:
- Hyponatraemia.
- Suicidal ideation and suicidal behaviour.
- Psychosis.
- Serotonin syndrome (see Drug Interactions for more detail).
- Systemic or cutaneous lupus erythematosus
- Panic attacks.
Drug interactions
- Drug interactions may occur if bupropion is taken concurrently with:
- Benzodiazepines — concurrent use is contraindicated when withdrawing benzodiazepines (or any other drug associated with seizures on withdrawal).
- Carbamazepine, phenytoin, phenobarbital, and primidone — monitor for evidence of reduced efficacy of bupropion (most likely) and/or increased toxicity (due to raised metabolite). Note that bupropion is contraindicated in people with current or past seizure disorders.
- Flecainide — levels may be increased if taken concurrently with bupropion. Reduce the dose of flecainide if required.
- Digoxin — levels may be decreased if taken concurrently with bupropion. Digoxin levels may rise on discontinuation of bupropion and the patient should be monitored for possible digoxin toxicity.
- HIV protease inhibitors (ritonavir) — levels of bupropion are reduced. Start bupropion at the recommended dose and titrate as required.
- Levodopa — monitor carefully for increased toxicity of levodopa.
- Monoamine oxidase inhibitor (MAOI) — bupropion toxicity may be enhanced if taken concurrently with an MAOI, leading to severe hypertension. Concurrent use is contraindicated for two weeks after stopping an MAOI.
- For moclobemide (a reversible MAOI), this period can be reduced to 24 hours.
- Sodium valproate — monitor for evidence of increased bupropion toxicity (due to increased levels of an active metabolite) or sodium valproate toxicity as high-dose bupropion may increase valproate levels. Note that bupropion is contraindicated in people with current or past seizure disorders.
- Tamoxifen — concurrent use with bupropion may reduce the metabolism of tamoxifen to one of its active metabolites. Avoid concurrent use.
- Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) — risk of serotonin syndrome if taken concurrently with bupropion. If concurrent treatment is required, monitor for adverse effects, particularly when initiating treatment or increasing doses. The MHRA advises that people using bupropion with an SSRI or SNRI should never exceed their prescribed dose and should be counselled on the milder symptoms of serotonin syndrome and advised to seek medical attention should these occur.
- Other drugs known to lower the seizure threshold — concurrent use with bupropion will increase the likelihood of seizures. A maximum dose of 150 mg is recommended when taken with drugs that lower the seizure threshold, including:
- Antipsychotics (risperidone and thioridazine).
- Antidepressants (fluoxetine, paroxetine, and sertraline).
- Antimalarials (mefloquine).
- Aminophylline and theophylline.
- Corticosteroids.
- Quinolones (ciprofloxacin and ofloxacin).
- Sedating antihistamines (chlorphenamine and clemastine).
- Tramadol.
Monitoring
- The manufacturer recommends that a baseline BP should be measured at the start of treatment and monitored during treatment, especially in people with pre-existing hypertension.
- If there is a clinically relevant increase in BP, bupropion should be stopped.
Pregnancy and breastfeeding
Pregnancy
- Bupropion should be avoided in women who are pregnant.
Breastfeeding
- Bupropion and its active metabolites are excreted in breastmilk.
- Bupropion should be avoided in women who are breastfeeding.
Varenicline
Mode of action of varenicline
- Varenicline is a partial nicotinic receptor agonist. It alleviates symptoms of craving and withdrawal, and reduces the rewarding and reinforcing effects of smoking by preventing nicotine binding to the receptors.
Dose and duration
- Varenicline should be started while the person is still smoking.
- Advise the person to stop smoking 7–14 days after starting varenicline.
- The recommended treatment dose is 1 mg varenicline twice daily following a 1-week titration as follows:
- Days 1–3: 500 micrograms once a day.
- Days 4–7: 500 micrograms twice a day.
- Day 8 onwards: 1 mg twice a day.
- For people who cannot tolerate the adverse effects of higher doses (1 mg twice daily) of varenicline, the dose may be reduced to 500 micrograms twice a day.
- For people with severe renal impairment (estimated creatinine clearance less than 30 mL/min), the recommended dose is varenicline 1 mg once a day. Dosing should begin at 0.5 mg once a day for the first 3 days, then increased to 1 mg once a day.
- The recommended course of treatment is 12 weeks.
- For people who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks of treatment with varenicline at 1 mg twice daily may be considered to help maintain abstinence.
- Varenicline may be stopped without tapering the dose. However, immediately after stopping treatment with varenicline, up to 3% of people experience an increase in irritability, urge to smoke, depression, or insomnia.
- Consider tapering the dose in these people.
Contraindications and cautions
- Do not prescribe varenicline to people:
- Aged under 18 years.
- With end-stage renal disease.
- Prescribe varenicline with caution to people with:
- A history of cardiovascular disease.
- A history of psychiatric illness.
- Epilepsy, or a predisposition to seizures.
- Moderate renal impairment (creatinine clearance [CrCl] 30–50 mL/min) — for people who experience adverse reactions that are not tolerable, reduce dose to 1 mg once daily.
- Severe renal impairment (CrCl less than 30 mL/min) — the starting dose is 0.5 mg once a day for the first 3 days, then 1 mg once daily.
Adverse effects
- Adverse effects of varenicline include:
- Cardiac — myocardial infarction, angina pectoris, tachycardia, and palpitations (uncommon).
- Rarely: atrial fibrillation, ST segment depression, and T wave amplitude decreased.
- Gastrointestinal — nausea (very common); vomiting, constipation, diarrhoea, abdominal distension and discomfort, dyspepsia, flatulence, toothache, and dry mouth (common).
- Rarely: haematemesis, abnormal faeces, and coated tongue.
- Nervous system — headache (very common); somnolence, dizziness, and dysgeusia (common).
- Rarely: cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, and circadian rhythm sleep disorder.
- Psychiatric — abnormal dreams, insomnia (very common); suicidal thoughts and behaviours, aggression, panic reaction, restlessness, depression, anxiety, and hallucinations (uncommon).
- Rarely: psychosis, somnambulism, abnormal behaviour, dysphoria, and bradyphrenia.
- Note: people should be advised that if serious neuropsychiatric symptoms occur while taking varenicline, it should be discontinued and they should contact a healthcare professional for re-evaluation of treatment.
- Cardiac — myocardial infarction, angina pectoris, tachycardia, and palpitations (uncommon).
- Other adverse effects include:
- Arthralgia and myalgia.
- Bronchitis, nasopharyngitis, and fungal infection.
- Chest pain.
- Dyspnoea and cough.
- Fatigue.
- Rash, pruritus, Stevens-Johnson syndrome, erythema multiforme, and angioedema.
- Tinnitus.
- Visual disturbances.
- Weight increases, appetite changes, hyperglycaemia, and diabetes mellitus.
Drug interactions
- There are no known clinically relevant drug interactions with varenicline.
Pregnancy and breastfeeding
Pregnancy
- The manufacturer advises that varenicline should be avoided in women who are pregnant.
Breastfeeding
- It is unknown whether varenicline is excreted in breastmilk — it should be avoided in women who are breastfeeding.
- Cytisinicline is a partial nicotinic receptor agonist. It alleviates symptoms of craving and withdrawal, and reduces the rewarding and reinforcing effects of smoking by preventing nicotine binding to the receptors.
- One pack of cytisinicline contains 100 tablets which should be sufficient for a complete course, as the duration of therapy is 25 days.
- Advise that smoking should be stopped no later than the fifth day of treatment.
- People with renal or hepatic impairment should not be prescribed cytisinicline.
- The treatment schedule is outlined in table 1.
Table 1: Treatment schedule
| Days of treatment | Recommended dosing | Maximum daily dose |
| Day 1–3 | 1 tablet every 2 hours | 6 tablets |
| Day 4–12 | 1 tablet every 2.5 hours | 5 tablets |
| Day 13–16 | 1 tablet every 3 hours | 4 tablets |
| Day 17–20 | 1 tablet every 5 hours | 3 tablets |
| Day 21–25 | 1 to 2 tablets per day | 2 tablets |
- Do not prescribe cytisinicline to:
- People under 18 years of age.
- People 66 years of age, or older.
- People with unstable angina, arrhythmias, recent myocardial infarction, or recent stroke.
- People with renal or hepatic impairment.
- Prescribe cytisinicline with caution in people with:
- A history of cardiovascular disease, including peripheral vascular disease.
- Hypertension.
- Gastric or duodenal ulcer or gastrointestinal reflux.
- Phaeochromocytoma.
- Hyperthyroidism.
- Diabetes mellitus.
- History of psychiatric illness (may exacerbate underlying illness including depression).
- Schizophrenia.
- Common adverse effects of cytisinicline include:
- Anxiety or mood alteration, appetite change, impaired concentration and fatigue, constipation, diarrhoea, nausea, dizziness, drowsiness, dry mouth, headache, tachycardia, vomiting, and myalgia. The manufacturer advises that some of these may also be the result of smoking cessation.
- Less common adverse effects include:
- Dyspnoea, excessive lacrimation, hyperhidrosis, decreased libido, and increase in sputum production.
- Cytisinicline should not be used with antituberculosis medications.
- Cytisinicline may reduce the effectiveness of combined hormonal contraceptives. The manufacturer recommends the use of additional (barrier) methods of contraception.
- The manufacturer advises that cytisinicline should be avoided in pregnancy and breastfeeding.
Which drugs are affected by stopping smoking?
- Smoking cigarettes (not nicotine) increases the metabolism of some medicines by stimulating the hepatic enzyme CYP1A2. When smoking is stopped, the dose of these drugs may need to be reduced, and the person monitored regularly for adverse effects [BNF, 2023; SPS, 2020].
- Most interactions between medicines and smoking are not clinically significant, but there are a small number of medicines that may need increased monitoring or dose adjustment when a person stops smoking [SPS, 2020]. See Table 1.
Table 1. Drugs affected by smoking cessation that are of high or moderate clinical relevance.
| Drug name | Action to take when stopping smoking |
|---|---|
| Aminophylline, Theophylline (narrow therapeutic index drugs) | Monitor plasma theophylline concentrations and adjust the dose of theophylline accordingly. The dose of theophylline may need to be reduced by about one-quarter to one-third one week after withdrawal. However, it may take several weeks for enzyme induction to dissipate. Monitor theophylline concentration periodically. Advise the person to seek help if they develop signs of theophylline toxicity such as palpitations or nausea. |
| Chlorpromazine | Be alert for increased adverse effects of chlorpromazine (for example, dizziness, sedation, extra-pyramidal symptoms). If adverse effects occur, reduce the dose as necessary. |
| Clozapine | Monitor serum drug levels before stopping smoking and one week after stopping smoking. On stopping smoking, reduce the dose gradually over a week until around 75% of the original dose is reached. Repeat plasma level one week after stopping smoking. Further dose reductions may be required. |
| Erlotinib | When given to people who smoke, increase the daily dose in 50mg increments at 2-week intervals, up to a maximum dose of 300mg. If the person stops smoking the dose should be immediately reduced to the initial starting dose. |
| Flecainide | Dose reductions may be necessary if the person stops smoking, as flecainide concentrations are reduced by 50% in people who smoke. |
| Methadone | Be alert for signs of opioid toxicity and reduce the methadone dose accordingly. |
| Olanzapine | Be alert for increased adverse effects of olanzapine (for example, dizziness, sedation, hypotension). If adverse effects occur, reduce the dose as necessary. If olanzapine plasma level monitoring is available, take a level before the person stops smoking and repeat one week after any dose changes. |
| Riociguat | Dose reductions may be necessary if the person stops smoking, as riociguat concentrations are reduced by 50-60% in people who smoke. |
| Warfarin (narrow therapeutic index drug) | If a person taking warfarin stops smoking, their INR might increase so monitor the INR more closely. Advise people to tell the healthcare professional managing their anticoagulant control that they are stopping smoking. |
| Information from: [SPS, 2020] | |
Note: This information applies to people who stop smoking, regardless of whether they use NRT or not.
Supporting evidence
This topic is largely based on the National Institute for Health and Care Excellence (NICE) guideline Tobacco: preventing uptake, promoting quitting and treating dependence [NICE, 2025] and Quality Standard Tobacco: treating dependence [NICE, 2022]; the National Centre for Smoking Cessation and Training (NCSCT) Local stop smoking services: service and delivery guidance 2014 [NCSCT, 2014] and Standard treatment programme [NCSCT, 2019a]; the Royal College of Physicians (RCP) report Nicotine without smoke: tobacco harm reduction [RCP, 2016]; a health technology assessment Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study [Dobbie, 2015]; the Scottish Intercollegiate Guidelines Network (SIGN) guideline Risk estimation and the prevention of cardiovascular disease [SIGN, 2017]; narrative reviews Supporting smoking cessation [Zwar, 2014] and Drugs for smoking cessation [Hartmann-Boyce, 2016]; and evidence from Cochrane systematic reviews [Cahill, 2013; Cahill, 2016; Stead, 2016; Hartmann-Boyce, 2018; Hartmann-Boyce, 2019; Lindson, 2019a; Lindson, 2019b; Howes, 2020; Hartmann-Boyce, 2022].
How this topic was developed
This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.
Search strategy
Scope of search
A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of smoking cessation.
Search dates
February 2018 - April 2023
Key search terms
Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.
- exp Smoking Cessation/, (smoking adj cessation).tw., exp "Tobacco Use Cessation Products"/, exp Tobacco/, exp "Tobacco Use Cessation"/, (cigar$ or smok$ or tobacco$ or nicotine).tw., (cessation or quit$ or (giv$ adj up) or reduc$).tw., (smokefree or (smoke adj free)).tw.
Sources of guidelines
- National Institute for Health and Care Excellence (NICE)
- Scottish Intercollegiate Guidelines Network (SIGN)
- Royal College of Physicians
- Royal College of General Practitioners
- Royal College of Nursing
- NICE Evidence
- World Health Organization
- Guidelines International Network
- TRIP database
- Agency for Healthcare Research and Quality
- National Health and Medical Research Council (Australia)
- Royal Australian College of General Practitioners
- British Columbia Medical Association
- Canadian Medical Association
- Alberta Medical Association
- Michigan Quality Improvement Consortium
- Singapore Ministry of Health
- National Resource for Infection Control
- RefHELP NHS Lothian Referral Guidelines
- Medline (with guideline filter)
- Driver and Vehicle Licensing Agency
- NHS Health at Work (occupational health practice)
Sources of systematic reviews and meta-analyses
- The Cochrane Library:
- Systematic reviews
- Protocols
- Database of Abstracts of Reviews of Effects
- Medline (with systematic review filter)
- EMBASE (with systematic review filter)
Sources of health technology assessments and economic appraisals
- NIHR Health Technology Assessment programme
- The Cochrane Library:
- NHS Economic Evaluations
- Health Technology Assessments
- Canadian Agency for Drugs and Technologies in Health
- International Network of Agencies for Health Technology Assessment
Sources of randomized controlled trials
- The Cochrane Library:
- Central Register of Controlled Trials
- Medline (with randomized controlled trial filter)
- EMBASE (with randomized controlled trial filter)
Sources of evidence based reviews and evidence summaries
Sources of national policy
- Department of Health
- Health Management Information Consortium (HMIC)
Patient experiences
Sources of medicines information
The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.
Stakeholder engagement
Our policy
The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:
- Clinical accuracy.
- Consistency with other providers of clinical knowledge for primary care.
- Accuracy of implementation of national guidance (in particular NICE guidelines).
- Usability.
Principles of the consultation process
- The process is inclusive and any individual may participate.
- To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
- Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
- Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
- External reviewers are not paid for commenting on the draft topics.
- Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
- All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
- All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.
Stakeholders
- Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
- Stakeholders identified from the following groups are invited to review draft topics:
- Experts in the topic area.
- Professional organizations and societies (for example, Royal Colleges).
- Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
- Guideline development groups where the topic is an implementation of a guideline.
- The British National Formulary team.
- The editorial team that develop MeReC Publications.
- Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.
Patient engagement
Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:
- Topic selection
- Scoping of topic
- Selection of clinical scenarios
- First draft internal review
- Second draft internal review
- External review
- Final draft and pre-publication
Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.
Evidence exclusion criteria
Our policy
Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.
Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.
Standard exclusions for scoping literature:
- Animal studies
- Original research is not written in English
Possible exclusions for reviewed literature:
- Sample size too small or study underpowered
- Bias evident or promotional literature
- Population not relevant
- Intervention/treatment not relevant
- Outcomes not relevant
- Outcomes have no clear evidence of clinical effectiveness
- Setting not relevant
- Not relevant to UK
- Incorrect study type
- Review article
- Duplicate reference
Organizational, behavioural and financial barriers
Our policy
The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.
- Feasibility
- Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
- Organizational and Financial Impact Analysis
- Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
- Eligible population
- Current interventions
- Likely uptake of new intervention or recommendation
- Cost of the current or new intervention mix
- Impact on other costs
- Condition-related costs
- In-direct costs and service impacts
- Time dependencies
- Cost-effectiveness or cost-benefit analysis studies are identified where available.
We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.
Declarations of interest
Our policy
Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:
- Personal financial interests
- Personal family interest
- Personal non-financial interest
- Non-personal financial gain or benefit
Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.
Who should declare competing interests?
Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.
Competing interests declared for this topic:
None.
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