Varenicline for tobacco dependence treatment in recovering alcohol-dependent smokers: an open-label pilot study.

The purpose of this study was to obtain preliminary evidence of the efficacy of a 12-week course of varenicline for 7-day point prevalence smoking abstinence among recovering alcohol-dependent smokers. We enrolled 32 smokers with 6 months or more of recovery from alcohol dependence in an open-label clinical trial. Participants received varenicline 1 mg twice daily and 12 weeks of behavioral counseling. Participants were 69% men, 94% Caucasian, and smoking an average of 20.3 ± 5.0 cigarettes per day. After 12 weeks of treatment, 31% were biochemically confirmed 7-day point prevalence abstinent from smoking and 28% had prolonged smoking abstinence (2 weeks after target quit date onward). The most common adverse effects were mild to moderate nausea (28%) and sleep disturbance (19%). No serious adverse events were reported. Varenicline may be a useful aid for treating tobacco dependence among smokers who are in stable recovery from alcohol dependence. Further study of this treatment is warranted.