Alcoholism Clinical Trial
Official title:
A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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