Safety and Efficacy of Varenicline for Smoking Cessation in Alcohol-Dependent Smokers in Concurrent Treatment for Alcohol Use Disorder: A Pilot, Randomized Placebo-Controlled Trial.

BACKGROUND: Smoking prevalence among those with alcohol dependence is much higher than the general population. Despite this, cessation treatment in those with concurrent alcohol dependence is seldom undertaken. We conducted a randomized, placebo-controlled, double-blind pilot study, whereby patients enrolled at an addiction treatment facility in downtown Toronto, Canada, were recruited and assigned to placebo or varenicline treatment for 12 weeks. We hypothesized that varenicline would be a safe and efficacious treatment for tobacco dependence in this population.

METHODS: Daily dependent smokers in treatment for alcohol dependence and interested in participating in the study were first screened over the phone and then assessed in-person. If eligible, they were randomly assigned to placebo or varenicline in a double-blind fashion. They attended weekly appointments for smoking cessation counseling and completed daily diaries for the full 12 weeks of treatment.

RESULTS: Thirty-one subjects were randomized to either varenicline (n = 16) or placebo treatment (n = 15). Participants were predominantly male (73.3%) with a mean age of 44.6 (23-66). Only one subject in the placebo group was quit by end of treatment (7-day point prevalence abstinence), compared with 7 in the varenicline group (χ(1) = 5.56, P = 0.037). Both groups had a significant decline in cigarettes per day (CPD) by end of treatment (varenicline = 22.1 ± 13.3 to 2.0 ± 3.0 CPD, t(10) = 4.45, P = 0.001; placebo: 14.9 ± 4.4 to 5.3 ± 6.3 CPD, t(13) = 3.61, P = 0.003).

CONCLUSIONS: The results from this pilot study indicate that varenicline is a safe and effective treatment for tobacco dependence in a sample of alcohol-dependent smokers undergoing concurrent treatment for alcohol use disorder.