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Completed Phase 2 Interventional Results available

Varenicline for Alcohol Dependence

ClinicalTrials.gov ID: NCT01146613

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT01146613. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 15, 2026, 12:57 AM EST

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01146613
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
200 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2011 (Type not available)
Primary completion
Jun 2012 (Actual)
Completion
Jul 2012 (Actual)
Last update posted
Aug 27, 2014

2011 – 2012

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
7
Facility City State ZIP Site status
Johns Hopkins University School of Medicine Baltimore Maryland 21224 —
Boston Medical Center Boston Massachusetts 02118 —
Dartmouth Medical School Bedford New Hampshire 03110 —
Dartmouth Medical School Hanover New Hampshire 03755 —
University of Pennsylvania Philadelphia Pennsylvania 19103 —
University of Virginia Charlottesville Virginia 22911 —
University of Virginia Richmond Virginia 23294 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01146613, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2014 · Synced Nov 15, 2026

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