Prescribing Prevalence, Effectiveness, and Mental Health Safety of Smoking Cessation Medicines in Patients With Mental Disorders
Open accessAbstract
Objective: We conducted a prospective cohort study of the Clinical Practice Research Database to estimate rates of varenicline and nicotine replacement therapy (NRT) prescribing and the relative effects on smoking cessation, and mental health. Methods: We used multivariable logistic regression, propensity score matched regression, and instrumental variable analysis. Exposure was varenicline or NRT prescription. Mental disorders were bipolar, depression, neurotic disorder, schizophrenia, or prescriptions of antidepressants, antipsychotics, hypnotics/anxiolytics, mood stabilizers. Outcomes were smoking cessation, and incidence of neurotic disorder, depression, prescription of antidepressants, or hypnotics/anxiolytics. Follow-ups were 3, 6, and 9 months, and at 1, 2, and 4 years. Results: In all patients, NRT and varenicline prescribing declined during the study period. Seventy-eight thousand four hundred fifty-seven smokers with mental disorders aged ≥18 years were prescribed NRT (N = 59 340) or varenicline (N = 19 117) from September 1, 2006 to December 31, 2015. Compared with smokers without mental disorders, smokers with mental disorders had 31% (95% CI: 29% to 33%) lower odds of being prescribed varenicline relative to NRT, but had 19% (95% CI: 15% to 24%) greater odds of quitting at 2 years when prescribed varenicline relative to NRT. Overall, varenicline was associated with decreased or similar odds of worse mental health outcomes than NRT in patients both with and without mental disorders, although there was some variation when analyses were stratified by mental disorder subgroup. Conclusions: Smoking cessation medication prescribing may be declining in primary care. Varenicline was more effective than NRT for smoking cessation in patients with mental disorders and there is not clear consistent evidence that varenicline is adversely associated with poorer mental health outcomes. Implications: Patients with mental disorders were less likely to be prescribed varenicline than NRT. We triangulated results from three analytical techniques. We found that varenicline was more effective than NRT for smoking cessation in patients with mental disorders. Varenicline was generally associated with similar or decreased odds of poorer mental health outcomes (ie, improvements in mental health) when compared with NRT. We report these findings cautiously as our data are observational and are at risk of confounding.
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People with depression or anxiety are twice as likely to smoke than those without.
“People with depression or anxiety are twice as likely to smoke than those without.”
From intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi-centre, acceptability and feasibility trial with nested qualitative methods (2025) · cites this paper as [6]
The Background says smoking prevalence among people with mental disorders was estimated at around twice the rate in the general population. It does not give that twofold estimate specifically for people with depression or anxiety compared with people without those conditions. The Results likewise report prevalence for any mental disorder, not those two conditions separately. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn the UK, approximately 32% of people with depression or anxiety are smokers (2015 estimates).
“In the United Kingdom, the latest estimates from 2015 show that approximately 32% of people with depression or anxiety are smokers [5, 6].”
From intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi-centre, acceptability and feasibility trial with nested qualitative methods (2025) · cites this paper as [6]
The Results section reports that age- and sex-standardised smoking prevalence was 32.0% in 2015 among people with any mental disorder diagnosis. It does not give that figure specifically for people with depression or anxiety, so the claim narrows the population beyond what the reported estimate supports. (LLM, conf=0.86)
Experimental — accuracy not yet measuredEvidence now suggests that varenicline does not cause psychological disturbance.
“Although evidence now suggests that varenicline does not cause psychological disturbance [6, 42]”
From intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi-centre, acceptability and feasibility trial with nested qualitative methods (2025) · cites this paper as [6]
The Results (Mental Health Safety) report generally similar or lower odds of measured mental-health outcomes with varenicline than with NRT. But they also report an increased likelihood of depression diagnosis in some subgroups, and the Discussion cautions that the observational findings may be confounded. The paper therefore supports a cautious safety statement, not the unqualified claim that varenicline does not cause psychological disturbance. (LLM, conf=0.85)
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“Cardiovascular disease and bipolar disorder were selected as illness contexts due to their high smoking prevalence and the gap in cessation support provided to patients with these conditions (Heffner et al., 2011; Taylor et al., 2019; Wu et al., 2025; Ziedonis et al., 2008).”
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“Medications including varenicline, bupropion, and nicotine replacement combined with behavioral therapies have been shown to successfully achieve smoking cessation and reduce morbidity and mortality in patients with schizophrenia.(1,12,14) Varenicline, in particular, combined with group-based behavioral support, seems…”
BackgroundBlackwell, A. K. M., Daryan, S., Roy, D. R., Duffy, D. J., Hisler, G. C., Sawyer, K., Ainsworth, B., Richards, D., Hiscock, D., Papadakis, S., et al. (2024) · Contemporary Clinical Trials · doi:10.1016/j.cct.2024.107541 · Cited by 2 · see citing works
“The feasibility and acceptability outcome measures were derived from previous epidemiological studies which indicated that approximately 25% of people referred for online CBT for common mental health problems should meet eligibility criteria (smoker, aged 18 + ) [4,19].”
InfluentialSelf-citationEvaluation of Adults' Intention to Quit Smoking and Related Factors in a Primary Care Center
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Physical Health in Psychosis: a Perspective on the Recovery Paradigm
Zierotin, A., Norton, M. J., O'Donoghue, B. N., O’Connor, K., & Clarke, M. (2025) · Irish Journal of Psychological Medicine · doi:10.1017/ipm.2025.1 · Cited by 1 · see citing works
“Additionally, misconceptions about the neuropsychiatric safety of medications such as varenicline may contribute to declining prescribing rates of smoking cessation medicines in those with mental health challenges (Taylor et al., 2019).”
Varenicline (Chantix): The Smoking Cessation Medication Prescribers May Be Avoiding
Mills, J. (2022) · Issues in Mental Health Nursing · doi:10.1080/01612840.2022.2061806 · Cited by 1 · see citing works
Sawyer, K., Burke, C., Ng, R. L. Y., Freeman, T. P., Adams, S. H., & Taylor, G. M. J. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.869158 · Cited by 1 · see citing works
“However, people with common mental health conditions such as anxiety and depression, are twice as likely to smoke than the general population (5, 6).”
BackgroundSelf-citationSmoking and mental health conditions: What you need to know
Chew-Graham, C. A., Shiers, D., Johnston, M. G., Farley, A., Burn, P. W., Clark, D. M., & Campion, J. (2023) · InnovAiT Education and inspiration for general practice · doi:10.1177/17557380231185161 · Cited by 1 · see citing works
Identifying Cigarette Smoking Trajectories from Homelessness to Housing
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“…of concern cessation medications may worsen mental health or inhibit psychotropic medication effectiveness—despite research suggesting they are generally safe for this population and that quitting smoking positively affects mood regulation (Evins et al., 2021; Prochaska, 2011; Taylor et al., 2020).”
Lee, J. H., & Lee, E. S. (2019) · Korean Journal of Stress Research · doi:10.17547/kjsr.2019.27.4.298 · Cited by 1 · see citing works
“, 2016)에서 금연 약물 치료의 효과가 입증되고 부작용 이 높지 않다는 결과 발표 이후 정서장애 흡연자를 대상으 로 한 연구가 점차 증가하고 있다(Taylor et al., 2019).”
Hindocha, C., Brose, L. S., Walsh, H., & Cheeseman, H. (2020) · doi:10.32388/2f4aq1.2 · Cited by 1 · see citing works
Taylor, G. M. J., & Hartmann‐Boyce, J. (2020) · Addiction · doi:10.1111/add.15315 · Cited by 1 · see citing works
Self-citationTreur, J. L. (2022) · Addiction · doi:10.1111/add.15802 · Cited by 1 · see citing works
“In reality, this is probably the group that could benefit most from smoking cessation [12].”
BackgroundLa agricultura mediterránea de la provincia de Granada
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Stein, K. F., Sawyer, K., Daryan, S., Allen, J. L., & Taylor, G. M. J. (2022) · medRxiv · doi:10.1101/2022.03.23.22272703
“There are many reasons for high smoking rates in this population, for example they are less likely to be prescribed smoking medicines (6), and it is widely believed that smoking cessation can worsen mental health (7, 8).”
BackgroundSelf-citationEvins, A. E., Cather, C., Maravić, M. C., Reyering, S., Pachas, G. N., Thorndike, A. N., Levy, D. E., Fung, V., Fischer, M. A., Schnitzer, K., et al. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4047139
Evidence of Mental Health Support and the Pharmacist
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Evidence of Mental Health Support and the Pharmacist
Henman, M. C. (2023) · Springer eBooks · doi:10.1007/978-3-030-64477-2_100
Association of depression and smoking cessation: outcomes of an 18-year retrospective cohort study
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Management of cardiovascular disease in patients with schizophrenia
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Taylor, G. M. J., Jacobsen, P. C., Blackwell, A. K. M., Daryan, S., Roy, D. R., Duffy, D. J., Hisler, G. C., Sawyer, K., Ainsworth, B., Hiscock, D., et al. (2025) · JMIR Mental Health · doi:10.2196/78424
Self-citationAn Update for Varenicline (Chantix) in 2026: Still Effective and Still Safe
Mills, J. (2026) · Issues in Mental Health Nursing · doi:10.1080/01612840.2026.2679935
“Individuals with mental illness are now less likely to be prescribed varenicline (Taylor et al., 2020).”
Chen, H., Luk, T. T., Yip, A. O. N., Guo, Z., Zhao, S., Chan, S. S. C., Lam, T. H., Cheung, Y. T. D., & Wang, M. P. (2026) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2026.06.001
- Authors
- Taylor, G. M. J., Itani, T., Thomas, K. H., Rai, D., Jones, T., Windmeijer, F., Martin, R. M., Munafò, M. R., Davies, N. M., & Taylor, A. E.
- Affiliations
- University of Bristol (GB)
- University Hospitals Bristol NHS Foundation Trust (GB)
- Medical Research Council Integrative Epidemiology Unit, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
- Corresponding author
- Taylor, Gemma M J
- ORCID
- Venue
- Nicotine & Tobacco Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-07-10
- Volume
- 22
- Issue
- 1
- Pages
- 48-57
- ISSN
- 1462-2203 (ISSN-L)
- 1469-994X
- PMC
- PMC7073926
- OpenAlex
- W2948641443
- Cited by
- 68
- References
- 35
- Citations by year
- 2026: 2 · 2025: 12 · 2024: 4 · 2023: 12 · 2022: 13 · 2021: 9 · 2020: 14 · 2019: 1
- FWCI
- 6.28
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Nicotine & Tobacco Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (submittedVersion, cc-by)
- Funders
- Cancer Research UK Population Researcher Postdoctoral Fellowship (C56067/A21330)
- Global Research Awards for Nicotine Dependence
- National Institute for Health Research
- Medical Research Council (MR/N01006X/1)
- University of Bristol (MC_UU_12013/6, MC_UU_12013/9)
- NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Keywords
- smoking cessation, varenicline, nicotine replacement therapy, mental illness, prescribing patterns, smoking cessation medication, depression, bipolar disorder, schizophrenia, antidepressants, mental health outcomes, primary care prescribing, propensity score matching, instrumental variables, smoking cessation effectiveness, drug safety, prescribing appropriateness
- MeSH terms
- Varenicline, Mental Disorders, Female, Humans, Male, Mental Health, Middle Aged, Nicotine, Drug Prescriptions, Prospective Studies, Tobacco Use Disorder, Smoking Cessation, Nicotinic Agonists, Tobacco Use Cessation Devices
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