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Does combining varenicline with the nicotine patch or extending cessation treatment duration increase smoking abstinence compared with the standard length of therapy with varenicline only?
In this randomized clinical trial that included 1251 participants smoking 5 cigarettes/d or more, treatment with varenicline monotherapy for 12 weeks, varenicline plus nicotine patch for 12 weeks, varenicline monotherapy for 24 weeks, and varenicline plus nicotine patch for 24 weeks resulted in 7-day point prevalence abstinence rates at 52 weeks of 25.1%, 23.6%, 24.4%, and 25.1%, respectively. None of the comparisons was statistically significant.
These findings do not support the use of combined varenicline plus nicotine patch vs varenicline monotherapy or of 24-week vs 12-week treatment for smoking cessation.
Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness.
To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration).
Design, Settings, and Participants
Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized.
All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311).
Main Outcomes and Measures
The primary outcome was carbon monoxide–confirmed self-reported 7-day point prevalence abstinence at 52 weeks.
Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, −0.4% [95% CI, −5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, −4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups.
Conclusions and Relevance
Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.
ClinicalTrials.gov Identifier: NCT03176784
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Corresponding Author: Timothy B. Baker, PhD, Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, 1930 Monroe St, Ste 200, Madison, WI 53711 (firstname.lastname@example.org).
Accepted for Publication: August 23, 2021.
Author Contributions: Dr Smith had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Baker, Piper, Smith, Stein, Fiore.
Acquisition, analysis, or interpretation of data: Baker, Piper, Smith, Bolt, Fiore.
Drafting of the manuscript: Baker, Smith, Fiore.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Smith, Bolt.
Obtained funding: Baker, Stein, Fiore.
Administrative, technical, or material support: Baker, Piper, Stein, Fiore.
Supervision: Baker, Piper.
Conflict of Interest Disclosures: Dr Baker reported receiving personal fees from the National Cancer Institute for editing a monograph and grants from the National Cancer Institute. Dr Bolt reported receiving grants from the National Institutes of Health. Dr Fiore reported receiving personal fees from the National Cancer Institute. No other disclosures were reported.
Funding/Support: Pfizer supplied the study with free active and placebo varenicline as per an investigator-initiated research agreement. This research was supported by grant 5R01HL109031 from the National Heart, Lung, and Blood Institute and grant K05CA139871 from the National Cancer Institute (both awarded to the University of Wisconsin Center for Tobacco Research and Intervention).
Role of the Funder/Sponsor: The funders/sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank Wendy Theobald, PhD, for providing vital assistance in editing and literature review, which was provided as part of her professional responsibilities related to her position as a researcher at the University of Wisconsin Department of Medicine. We are very grateful to the staff and students at the Center for Tobacco Research and Intervention at the University of Wisconsin School of Medicine and Public Health for their help with this research.
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