CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01146613
NCT01146613Phase 2Completed
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A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers

National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Jun 17, 2010·Updated Aug 27, 2014

In Brief

A Phase 2 clinical trial evaluating Varenicline and Placebo for Alcoholism. Completed, enrolled 200 participants across 7 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2010
Enrollment StartFeb 1, 2011
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.0 years ago

Interventions

Vareniclinedrug

0.5mg capsules x 2, 2x a day for 12 weeks

Placebodrug

identical matched placebo x 2, 2xday, 13 weeks