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NCT00183196 · ClinicalTrials.gov registry record · Phase 3
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
A Phase 3 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT00183196: Completed Phase 3 study, sponsored by Medical University of South Carolina.
NCT00183196 is a Phase 3 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00183196, a Phase 3 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.
Primary Outcome
Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.
Interventions
- OTHER Inactive Placebo
- DRUG Naltrexone
- DRUG Naltrexone plus Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00183196 record still lists
NCT00183196 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Inactive Placebo is the first listed.
NCT00183196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00183196 about?
NCT00183196 is a clinical study titled "Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone". The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decrea...
What is the current status of trial NCT00183196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2003-01. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00183196?
The interventions under investigation include: Inactive Placebo (OTHER), Naltrexone (DRUG), Naltrexone plus Gabapentin (DRUG).
Who is sponsoring clinical trial NCT00183196?
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 NCT00183196's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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