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NCT00006206 · ClinicalTrials.gov registry record · Phase 3
COMBINE (Acamprosate/Naltrexone)
A Phase 3 study of Alcoholism, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,375
- Enrollment target
- 12
- Study locations
NCT00006206 is a Phase 3 study of Alcoholism that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1,375 participants, above the 354-participant average among 65 other Alcoholism trials with a reported enrollment target (288% higher). The trial reports 12 study locations across 10 states.
The verdict
NCT00006206, a Phase 3 study of Alcoholism, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,375 participants
- Enrollment target
- 12
- Study locations
Study Summary
Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
Conditions Studied
Interventions
- DRUG naltrexone (Revia)
- DRUG acamprosate (Campral)
Study Locations (12)
Massachusetts
- Harvard University/McLean Hospital - Belmont
- Massachusetts General Hospital - Boston
- Boston University School of Medicine - Boston
Connecticut
- Substance Abuse Treatment Unit, Yale University - New Haven
Florida
- University of Miami School of Medicine - Miami
New Mexico
- Center on Alcoholism, Substance Abuse and Addiction, University of New Mexico - Albuquerque
Pennsylvania
- Treatment and Research Center, University of Pennsylvania - Philadelphia
Rhode Island
- Roger Williams Medical Center , Brown University - Providence
South Carolina
- Center for Alcohol Programs, Medical University of South Carolina - Charleston
Texas
- Southwest Texas Addiction Research and Technology Center, University of Texas Health Science Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,375 participants |
| Start Date | 1997-08 |
| Est. Completion | 2006-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006206
The ClinicalTrials.gov registry entry for NCT00006206 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,375 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 354-participant average among 65 other Alcoholism trials with a reported enrollment target (288% higher). 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 1 condition, with Alcoholism appearing as the primary indexed condition, and to 2 interventions - of which naltrexone (Revia) is the first listed.
NCT00006206 reports 12 study locations spanning 10 distinct geographic areas - top geographies include Massachusetts, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT00006206 about?
NCT00006206 is a clinical study titled "COMBINE (Acamprosate/Naltrexone)". Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the inte...
What is the current status of trial NCT00006206?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,375 participants. The study started on 1997-08. Estimated completion is 2006-05.
What conditions does trial NCT00006206 study?
This clinical trial studies the following conditions: Alcoholism.
What interventions are being tested in trial NCT00006206?
The interventions under investigation include: naltrexone (Revia) (DRUG), acamprosate (Campral) (DRUG).
Who is sponsoring clinical trial NCT00006206?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00006206 being conducted?
This trial has 12 study locations across Connecticut, Florida, Massachusetts, New Mexico, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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