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NCT00262639 · ClinicalTrials.gov registry record · Phase 2
Prometa Protocol for Alcohol Dependence
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00262639: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT00262639 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00262639, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote abstinence, and reduce drinking over approximately a six-week treatment period. All participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72 hours prior to receiving the first study drug. They will be injected one drug (flumazenil or placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo (inactive) drug group. Secondary outcomes that will be evaluated include reduction in craving, improvement in sleep, brain activity and mood.
Primary Outcome
percent of subjects completely abstinent during the six week medication study study
Interventions
- DRUG Placebo
- DRUG Flumazenil and Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00262639 record still lists
NCT00262639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00262639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00262639 about?
NCT00262639 is a clinical study titled "Prometa Protocol for Alcohol Dependence". This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will b...
What is the current status of trial NCT00262639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2005-12. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00262639?
The interventions under investigation include: Placebo (DRUG), Flumazenil and Gabapentin (DRUG).
Who is sponsoring clinical trial NCT00262639?
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 NCT00262639's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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