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Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette SmokingA Randomized Clinical Trial

Educational Objective
To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence.
1 Credit CME
Key Points

Question  Can treatment using varenicline tartrate and medical management reduce heavy drinking and increase smoking abstinence in individuals with alcohol use disorder and comorbid cigarette smoking?

Findings  In this phase 2, randomized, double-blind, parallel group, placebo-controlled trial involving 131 participants with alcohol use disorder, varenicline effects varied in men and women. Men taking varenicline demonstrated a benefit on measures of heavy drinking, whereas women had a better response taking placebo; 13% of participants quit smoking while taking varenicline, but no one quit while taking placebo.

Meaning  Varenicline, an approved smoking-cessation medication, may have a role in the treatment of alcohol use disorder among men who smoke cigarettes.


Importance  Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking.

Objectives  To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence.

Design, Setting, and Participants  This phase 2, randomized, double-blind, parallel group, placebo-controlled trial was conducted at 2 outpatient clinics from September 19, 2012, to August 31, 2015. Eligible participants met alcohol-dependence criteria and reported heavy drinking (≥5 drinks for men and ≥4 drinks for women) 2 or more times per week and smoking 2 or more times per week; 131 participants were randomized to either varenicline or placebo stratified by sex and site. All analyses were of the intention-to-treat type. Data analysis was conducted from February 5, 2016, to September 29, 2017.

Interventions  Varenicline tartrate, 1 mg twice daily, and matching placebo pills for 16 weeks. Medical management emphasized medication adherence for 4 weeks followed by support for changing drinking.

Main Outcomes and Measures  Percentage of heavy drinking days (PHDD) weeks 9 to 16, no heavy drinking days (NHDD) weeks 9 to 16, and prolonged smoking abstinence weeks 13 to 16.

Results  Of 131 participants, 39 (29.8%) were women and 92 (70.2%) were men, the mean (SD) age was 42.7 (11.7) years, and the race/ethnicity self-identified by most respondents was black (69 [52.7%]). Sixty-four participants were randomized to receive varenicline, and 67 to receive placebo. Mean change in PHDD between varenicline and placebo across sex and site was not significantly different. However, a significant treatment by sex by time interaction for PHDD (F1,106 = 4.66; P = .03) revealed that varenicline compared with placebo resulted in a larger decrease in log-transformed PHDD in men (least square [LS] mean difference in change from baseline, 0.54; 95% CI, −0.09 to 1.18; P = .09; Cohen d = 0.45) but a smaller decrease in women (LS mean difference, −0.69; 95% CI, −1.63 to 0.25; P = .15; Cohen d = −0.53). Thirteen of 45 men (29%) had NHDD taking varenicline compared with 3 of 47 men (6%) taking placebo (Cohen h = 0.64; 95% CI, 0.22-1.03), whereas 1 of 19 women (5%) had NHDD compared with 5 of 20 women (25%) taking placebo (Cohen h = −0.60; 95% CI, −1.21 to 0.04). Taking varenicline, 8 of 64 participants (13%) achieved prolonged smoking abstinence; no one (0 of 67) quit smoking taking placebo (P = .003; Cohen h = 0.72; 95% CI, 0.38-1.07).

Conclusions and Relevance  Varenicline with medical management resulted in decreased heavy drinking among men and increased smoking abstinence in the overall sample. Varenicline could be considered to promote improvements in men with these dual behavioral health risks.

Trial Registration  clinicaltrials.gov Identifier: NCT01553136

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Article Information

Corresponding Author: Stephanie S. O’Malley, PhD, Department of Psychiatry, Yale School of Medicine, 34 Park St, New Haven, CT 06519 (stephanie.omalley@yale.edu).

Accepted for Publication: October 2, 2017.

Published Online: December 20, 2017. doi:10.1001/jamapsychiatry.2017.3544

Author Contributions: Drs O’Malley and Zweben had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: O’Malley, Zweben, Fucito, Jatlow, Gueorguieva.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: O’Malley, Zweben, Fucito, Piepmeier, Wu, Bold, Petrakis, Muvvala, Gueorguieva.

Critical revision of the manuscript for important intellectual content: Zweben, Fucito, Ockert, Bold, Muvvala, Jatlow, Gueorguieva.

Statistical analysis: Wu, Bold, Gueorguieva.

Obtained funding: O’Malley, Zweben.

Administrative, technical, or material support: O’Malley, Zweben, Fucito, Piepmeier, Bold, Petrakis, Jatlow.

Study supervision: O’Malley, Zweben, Fucito, Ockert, Muvvala.

Conflict of Interest Disclosures: Dr O’Malley reported having been a consultant or an advisory board member for Alkermes, Amygdala, Arkeo, Cerecor, Mitsubishi Tanabe, Opiant, Pfizer; a member of the American Society of Clinical Psychopharmacology Alcohol Clinical Trials Initiative supported by Abbott, Amygdala, Ethypharm, Lilly, Lundbeck, Otsuka, Pfizer, Arbor Pharmaceuticals, and Indivior; a coinvestigator on studies receiving donated medications from Astra Zeneca, Novartis; a site principal investigator for a multisite trial by Lilly; and a scientific panel member for Hazelden Foundation. Dr Petrakis reported being a consultant to Alkermes. Dr Fucito reported registering with the US Patent and Trademark Office the name and content of a web-based program to help with sleeping and drinking (ie, Call it a Night). No other disclosures were reported.

Funding/Support: This trial was supported in part by grants R01AA020388, R01AA020389, P50AA012870, T32DA019426, K23AA020000, and K05AA014715 from the National Institutes of Health and by the State of Connecticut Department of Mental Health and Addiction Services. Pfizer generously donated varenicline and placebo pills.

Role of the Funder/Sponsor: The funding sources 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.

Disclaimer: This content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health, the Connecticut Department of Mental Health and Addiction Services, or the State of Connecticut.

Additional Contributions: The following people provided important contributions to the conduct of this trial: Armin Baier, JD, MSW, Parallax Center; Douglas Bass, MD, Parallax Center; David Forman, MSW, Columbia University; Elaine Lavelle, MS, Yale School of Medicine; Susan Neveu, Yale School of Medicine; and Denise Romano, APRN, MSN, MA, ADS-RT, Yale School of Medicine. These individuals were compensated for their contributions.

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