Conditions: Alcoholism
Keywords: Alcohol Alcohol abuse Alcoholism Alcohol Dependence Varenicline Drinking
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 200
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).

Detailed description:

Arms:
arm 1: Varenicline Tartrate arm 2: None

Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5mg capsules x 2, 2x a day for 12 weeks intervention 2: identical matched placebo x 2, 2xday, 13 weeks

Protocol document: