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NCT00877734 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Tolerability of Baclofen for Alcohol Dependence

A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT00877734: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.

NCT00877734 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00877734, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG placebo
  • DRUG baclofen
  • BEHAVIORAL BRENDA counseling

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2005-04
Est. Completion 2007-06
Phase Phase 2

What the finished NCT00877734 record still lists

NCT00877734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00877734 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00877734 about?

NCT00877734 is a clinical study titled "Efficacy and Tolerability of Baclofen for Alcohol Dependence". 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 counse...

What is the current status of trial NCT00877734?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2005-04. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00877734?

The interventions under investigation include: placebo (DRUG), baclofen (DRUG), BRENDA counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT00877734?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00877734's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00877734, the US trial registry maintained by the National Library of Medicine. NCT00877734 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.