NCT01146613

Varenicline for Alcohol Dependence

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Varenicline	0.5mg capsules x 2, 2x a day for 12 weeks
DRUG	Placebo	identical matched placebo x 2, 2xday, 13 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2010-06-17
• Last updated: 2014-08-27
• Results posted: 2014-08-11

Locations

7 sites across 1 country: United States