A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence - PubMed (original) (raw)

Clinical Trial

. 2013 Jul-Aug;7(4):277-86.

doi: 10.1097/ADM.0b013e31829623f4.

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; NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group

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Clinical Trial

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

Raye Z Litten et al. J Addict Med. 2013 Jul-Aug.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01146613.

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Figures

Figure 1

Figure 1. Subject Disposition

mITT = modified intention-to-treat * The mITT sample size of the varenicline group was decreased by n=2 from n=97 to 95 as one patient enrolled twice in the study (at two different study sites), gave invalid data and, consequently, both occurrences of the patient were excluded. The outcome analytic sample size of the varenicline group was further decreased to n=96 as an additional patient discontinued the study prior to reporting outcome data.

Figure 2

Figure 2. Weekly Differences Between Placebo and Varenicline on the Primary Outcome Measure, Percent Heavy Drinking Days, During Study Maintenance Phase (Weeks 2–13)

* p<.05; ** p<.01 Means are LSMEANS obtained during the maintenance period (Weeks 2-13) from a mixed model that includes treatment group, week, site, treatment goal, craving, baseline percent heavy drinking days, and treatment group by week interaction. Error bars are standard errors. Note: the treatment group by week interaction is statistically significant (p=0.011).

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