Journal of Addiction Medicine

Skip Navigation LinksHome > July/August 2013 - Volume 7 - Issue 4 > A Double-Blind, Placebo-Controlled Trial Assessing the Effic...
Journal of Addiction Medicine:
doi: 10.1097/ADM.0b013e31829623f4
Original Research

A Double-Blind, Placebo-Controlled Trial Assessing the Efficacy of Varenicline Tartrate for Alcohol Dependence

Litten, Raye Z. PhD; Ryan, Megan L. MBA; Fertig, Joanne B. PhD; Falk, Daniel E. PhD; Johnson, Bankole MD; Dunn, Kelly E. PhD; Green, Alan I. MD; Pettinati, Helen M. PhD; Ciraulo, Domenic A. MD; Sarid-Segal, Ofra MD; Kampman, Kyle MD; Brunette, Mary F. MD; Strain, Eric C. MD; Tiouririne, Nassima A. MD; Ransom, Janet PhD; Scott, Charles PhD; Stout, Robert PhD; for the NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group

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Objectives: To assess the efficacy and safety of varenicline (Chantix) for the treatment of alcohol dependence. Varenicline is a partial α4β2 nicotinic acetylcholine agonist approved by the Food and Drug Administration for smoking cessation. It has reduced drinking in animal studies and in small studies of humans who were both heavy drinkers and smokers. This is the first multisite clinical trial of varenicline in a population of smokers and nonsmokers with alcohol dependence.

Methods: Men and women (n = 200) meeting the criteria for alcohol dependence were recruited across 5 clinical sites. Patients received double-blind varenicline or placebo and a computerized behavioral intervention. Varenicline was titrated during the first week to 2 mg/d, which was maintained during weeks 2 to 13.

Results: The varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference = 10.4), drinks per day, drinks per drinking day, and alcohol craving compared with the placebo group (P < 0.05). The average treatment effect on alcohol use was similar for smokers and nonsmokers. Varenicline was well-tolerated; adverse events were expected and mild.

Conclusions: Varenicline significantly reduced alcohol consumption and craving, making it a potentially viable option for the treatment of alcohol dependence.

© 2013 American Society of Addiction Medicine

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