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NCT00466661 · ClinicalTrials.gov registry record · Phase 4
Acamprosate vs. Placebo in Bipolar Alcoholics
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT00466661: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT00466661 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00466661, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo. The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.
Primary Outcome
Number of days after randomization until consumption of first alcoholic beverage per self-report.
Interventions
- DRUG Placebo
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
What the finished NCT00466661 record still lists
NCT00466661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00466661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00466661 about?
NCT00466661 is a clinical study titled "Acamprosate vs. Placebo in Bipolar Alcoholics". To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar...
What is the current status of trial NCT00466661?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2007-04. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00466661?
The interventions under investigation include: Placebo (DRUG), Acamprosate (DRUG).
Who is sponsoring clinical trial NCT00466661?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00466661's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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