Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking.

Background: This study is the first to examine longitudinal posttreatment outcomes of a placebo-controlled trial of varenicline for alcohol use disorder (AUD) with comorbid cigarette smoking.

Methods: Participants were 131 adults (n = 39 female) seeking alcohol treatment in a randomized, double-blind, parallel group, placebo-controlled, 16-week multisite trial of varenicline combined with medical management (MM). Timeline follow-back assessments of alcohol and smoking behavior were conducted at the end of treatment (4 months), with follow-ups at 6, 9, and 12 months. Outcomes were percentage of heavy drinking days (PHDD), percent of participants with no heavy drinking days (NHDD), cotinine-confirmed prolonged smoking abstinence (PA), and good clinical outcome on either NHDD or PA.

Results: Treatment improvements were maintained posttreatment. For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months (p < 0.05). Significant differences were observed by sex: Males had higher rates of NHDD with varenicline (28.9%) versus placebo (6.4%) at the end of treatment (p = 0.004), and these effects were maintained at 12 months (varenicline: 40.0% vs. placebo: 19.2%, p = 0.03). Higher rates of PA were seen for varenicline in both males (8.9%) and females (21.1%) versus placebo (males/females: 0%) at the end of treatment (p = 0.05), and this effect was maintained at 12 months for females (varenicline: 21.1% vs. placebo, 0.0%, p = 0.05).

Conclusions: Varenicline treatment combined with MM appears to have enduring benefits for patients with co-occurring AUD and cigarette smoking, and these effects may differ by sex.