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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 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 80 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00877734
The ClinicalTrials.gov registry entry for NCT00877734 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00877734 reports 0 study locations.
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.
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