Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial

Abstract

Background: Tobacco use is prevalent among persons with alcohol abuse and dependence. Varenicline has been shown to be the most effective pharmacotherapy for smoking cessation and may decrease alcohol consumption. The purpose of this study was to evaluate the efficacy of 12 weeks of varenicline for increasing smoking abstinence rates in smokers with alcohol abuse or dependence.

Methods: Participants were eligible for enrollment if they were 18 years or older, smoked 10 or more cigarettes per day for at least 6 months, had current alcohol abuse or dependence, and were interested in quitting smoking. Participants were randomly assigned to receive 12 weeks of varenicline 1 mg twice daily or matching placebo. The primary end point was 7-day point prevalence smoking abstinence at week 12.

Results: The 7-day point prevalence smoking abstinence rate at 12 weeks was significantly higher with varenicline (n = 16) than placebo (n = 17) (43.8% vs 5.9%; P = .01). At 24 weeks, the 7-day point prevalence smoking abstinence rate was still significantly higher with varenicline than placebo (31.3% vs 0%; P = .02). At 12 weeks, mean (SD) drinks per drinking day was significantly lower with varenicline than placebo (5.7 [3.9] vs 9.0 [5.3] drinks; treatment effect estimate, -2.8 [90% CI, -6.6 to -1.0]). Adverse events were minor and comparable to varenicline clinical trials.

Conclusions: Varenicline is safe and efficacious for increasing smoking abstinence rates in smokers with alcohol abuse or dependence. Varenicline may decrease alcohol consumption in this population of smokers.

Keywords: Alcohol use disorder; Nicotine; Pharmacotherapy; Smoking cessation.

Conflict of interest statement

Conflict of Interest: R.T.H. reports research grants from Pfizer and the NIH. J.T.H. reports research grants from Pfizer. J.O.E. reports grants from Pfizer during the conduct of the study and grants from Takeda, the U.S. Department of Defense and the NIH outside the submitted work. R.D.H. reports a research grant from the NIH. All other others have nothing to disclose

Copyright © 2018 Elsevier B.V. All rights reserved.

Figures

Figure 1

CONSORT Diagram Showing Flow of Study Participants. BP indicates blood pressure; CPD, cigarettes per day; MINI, Mini-International Neuropsychiatric Interview.

Figure 2

Nicotine Cravings. Mean (SD) change in nicotine cravings from baseline before and after the target quit date (TQD).