Brief article Varenicline for tobacco dependence treatment in recovering alcohol-dependent smokers: An open-label pilot study J. Taylor Hays, (M.D.) a, ⁎ , Ivana T. Croghan, (Ph.D.) a , Darrell R. Schroeder, (M.S.) b , Jon O. Ebbert, (M.D.) a , Richard D. Hurt, (M.D.) a a Mayo Clinic, Nicotine Dependence Center, Rochester, Minnesota 55905 b Mayo Clinic, Division of Biostatistics, Rochester, Minnesota 55905 Received 28 May 2010; received in revised form 12 August 2010; accepted 18 August 2010 Abstract 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. © 2011 Elsevier Inc. All rights reserved. Keywords: Tobacco use disorder; Alcohol dependence; Smoking cessation; varenicline; Abstinence 1. Introduction Tobacco dependence and alcohol abuse comorbidity is common. The prevalence of smoking among alcohol- dependent individuals is two to three times that of the general population (Grant, Hasin, Chou, Stinson, & Dawson, 2004). Because of this, alcohol-dependent individuals are at increased risk for morbidity and mortality due to tobacco- caused diseases such as coronary heart disease, chronic lung disease, and lung and other aerodigestive tract cancers (U.S. Department of Health and Human Services, 2004). Fifty percent of smokers previously treated for alcoholism die of a tobacco-caused disease (Hurt et al., 1996). In addition, smokers with a history of alcohol problems show lower general and mental health status (Patten et al., 2001). These problems are potentially compounded because recovering alcohol-dependent smokers may be more severely dependent on tobacco than are their non-alcohol-dependent counter- parts and may have more difficulty achieving long-term smoking abstinence (Hughes & Kalman, 2006). Studies evaluating the efficacy of nicotine replacement therapy (NRT) among alcohol-dependent smokers have produced mixed findings (Hughes & Kalman, 2006; Hughes, Keely, et al., 2003; Hughes, Novy, Hatsukami, Jensen, & Callas, 2003; Hurt et al., 1995; Kalman, Kahler, Garvey, & Monti, 2006). Some reports indicate that although individuals Journal of Substance Abuse Treatment 41 (2011) 102 – 107 ClinicalTrials.gov identifier: NCT01092702. Drs. Hays, Hurt, Ebbert, and Croghan played a role in the study design, enrollment of participants, execution of the study protocol, interpretation of the data, preparation and critical review of the manuscript, and approval of the final manuscript for submission. Mr. Schroeder undertook the statistical analysis and contributed to the interpretation of the data, critical review of the manuscript, and approval of the final manuscript for submission. Drs. Hays, Croghan, and Ebbert and Mr. Schroeder report no conflicting financial interests. Dr. Hurt reports having served on a scientific advisory board for Pfizer. This study was supported by the Mayo Foundation for Medical Education and Research, Mayo Clinic Cancer Center, Division of General Internal Medicine, and Division of Primary Care Internal Medicine. ⁎ Corresponding author. Mayo Clinic, 200 First Street SW, Rochester, MN 55905. Tel.: +1 507 284 4921; fax: +1 507 284 4959. E-mail address: hays.taylor@mayo.edu (J.T. Hays). 0740-5472/10/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.jsat.2010.08.009