Moderators of Varenicline Treatment Effects in a Double-Blind, Placebo-Controlled Trial for Alcohol Dependence: An Exploratory Analysis

Abstract

Objectives: To explore whether varenicline (Chantix) showed more efficacy in treating certain subgroups of patients. In a recent multisite trial, varenicline was shown to be effective in reducing drinking in alcohol-dependent patients, both smokers and nonsmokers. Given the heterogeneity among alcohol-dependent patients, secondary analyses were conducted to determine whether certain subgroups responded more favorably than others to treatment with varenicline.

Methods: Data were drawn from a phase 2 randomized, double-blind, placebo-controlled multisite 13-week trial of varenicline in alcohol-dependent patients (Litten et al., 2013). Seventeen moderator variables were selected for exploratory testing on the basis of theoretical and scientific interest.

Results: Of the 17 moderator variables assessed, 4 were statistically significant, including cigarettes per day reduction, treatment drinking goal, years drinking regularly, and age of the patient. Two other variables—the type of adverse events experienced by patients and the severity of alcohol-related consequences—seemed to moderate the varenicline treatment effect at borderline statistical significance. Individuals who reduced the number of cigarettes per day experienced a significant effect from varenicline in reducing drinking, whereas those who did not change or who increased their number of cigarettes observed no beneficial effect. Reviewing the moderators related to severity, varenicline seemed to have greater efficacy than placebo among less severely dependent patients.

Conclusions: Varenicline seems to be more efficacious in certain subgroups, particularly in those who reduced their smoking and in the "less severe" patient. Additional studies are warranted to confirm the results of these exploratory analyses.

Trial registration: ClinicalTrials.gov NCT01146613.