Prescribing prevalence, effectiveness, and mental health safety of smoking cessation medicines in patients with mental disorders

Gemma Taylor, Taha Itani, Kyla H Thomas, Dheeraj Rai, Tim Jones, Frank Windmeijer, Richard Martin, Marcus R Munafò, Neil M. Davies, Amy E. Taylor

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37 Citations (SciVal)


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.
Original languageEnglish
Article numberntz072
Pages (from-to)48-57
JournalNicotine & Tobacco Research
Issue number1
Early online date10 Jul 2019
Publication statusPublished - 31 Jan 2020

Bibliographical note

Funding Information:
This research was supported by Global Research Awards for Nicotine Dependence (GRAND), an independently reviewed competitive grants program supported by Pfizer, to the University of Bristol. GTs salary was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 14/49/94) during the conduct of this research. The funders had no role in study design, data collection, and analysis, decision to publish, or preparation of the article. GT is currently funded by Cancer Research UK Population Researcher Postdoctoral Fellowship award (C56067/A21330). KHT was funded by a National Institute for Health Research (NIHR) Postdoctoral Fellowship (PDF-2017-10-068) for this research project. TJ receives funding from the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR CLAHRC) West. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The MRC Integrative Epidemiology Unit is supported by the Medical Research Council and the University of Bristol (MC_UU_12013/6, MC_ UU_12013/9). The research described in this article was partially funded by the Medical Research Council (MR/N01006X/1). This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The study sponsor and funder did not influence study conceptualization, design, analysis, interpretation, write up of any other part of this study and its conduct.

Funding Information:
GT, ND, and AT report a grant from Global Research Awards for Nicotine Dependence (GRAND), an independent grant making body funded by Pfizer, for the work conducted in this study. TI, TJ, RM, DR, FW, and KT have nothing to disclose. Dr. MRM reports grants from Pfizer, and grants and nonfinancial support from Rusan, outside the submitted work.

Publisher Copyright:
© 2019 The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.


  • varenicline
  • nicotine replacement therapy
  • mental health
  • smoking cessation
  • instrumental variable analyses
  • propensity score matching
  • triangulation
  • CPRD
  • primary care


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