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Completed Phase 2Phase 3 Interventional

Efficacy and Tolerability of Baclofen for Alcohol Dependence

ClinicalTrials.gov ID: NCT00877734

Public ClinicalTrials.gov record NCT00877734. 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 2, 2026, 5:37 PM EDT

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

Official title

Phase IIIa Trial of Baclofen for Alcohol Dependence

Brief summary

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

This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid) baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB) method will be used to assess drinking patterns. The primary outcome is % heavy drinking during the trial.

Study identification

NCT ID
NCT00877734
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Enrollment
80 participants

Conditions and interventions

Interventions

Drug · Behavioral

Eligibility (public fields only)

Age range
21 Years to 65 Years
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
Mar 31, 2005
Primary completion
Apr 30, 2007
Completion
May 31, 2007
Last update posted
Sep 13, 2012

2005 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of North Carolina at Chapel Hill School of Medicine Chapel Hill North Carolina 27599-7160

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 NCT00877734, 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 Sep 13, 2012 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00877734 live on ClinicalTrials.gov.

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