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NCT00000456 · ClinicalTrials.gov registry record · Phase 4
Behavioral Therapy Plus Naltrexone for Alcoholism
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
NCT00000456 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 160 participants.
The verdict
NCT00000456, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
Study Summary
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.
Interventions
- BEHAVIORAL cognitive behavior therapy
- DRUG naltrexone (Revia)
- BEHAVIORAL motivational enhancement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 1992-09 |
| Est. Completion | 2002-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000456
The ClinicalTrials.gov registry entry for NCT00000456 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which cognitive behavior therapy is the first listed.
NCT00000456 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000456 about?
NCT00000456 is a clinical study titled "Behavioral Therapy Plus Naltrexone for Alcoholism". This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychoso...
What is the current status of trial NCT00000456?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 1992-09. Estimated completion is 2002-08.
What interventions are being tested in trial NCT00000456?
The interventions under investigation include: cognitive behavior therapy (BEHAVIORAL), naltrexone (Revia) (DRUG), motivational enhancement therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00000456?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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