A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence

Raye Z. Litten, Megan L. Ryan, Joanne B. Fertig, Daniel E. Falk, Bankole Johnson, Kelly E. Dunn, Alan I. Green, Helen M. Pettinati, Domenic A. Ciraulo, Ofra Sarid-Segal, Kyle Kampman, Mary F. Brunette, Eric C. Strain, Nassima A. Tiouririne, Janet Ransom, Charles Scott, Robert Stout

Research output: Contribution to journalArticlepeer-review

159 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)277-286
Number of pages10
JournalJournal of addiction medicine
Issue number4
StatePublished - Jul 2013


  • Alcohol dependence
  • Alcohol use disorder
  • Champix
  • Chantix
  • Randomized placebo-controlled clinical trial
  • Varenicline

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)


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