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Completed Phase 2 Interventional Results available

Varenicline for Alcohol Dependence

ClinicalTrials.gov ID: NCT01146613

Public ClinicalTrials.gov record NCT01146613. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 27, 2026, 11:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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
Jan 31, 2011
Primary completion
May 31, 2012
Completion
Jun 30, 2012
Last update posted
Aug 26, 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 26, 2014 · Synced Sep 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01146613 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →