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NCT00006489 · ClinicalTrials.gov registry record · Phase 4
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 165
- Enrollment target
NCT00006489: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00006489 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 165 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006489, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 165 participants
- Enrollment target
Study Summary
This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.
Interventions
- DRUG Placebo
- DRUG Naltrexone
- BEHAVIORAL Cognitive-Behavioral Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2000-12 |
| Est. Completion | 2011-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006489
The ClinicalTrials.gov registry entry for NCT00006489 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00006489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006489 about?
NCT00006489 is a clinical study titled "Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)". This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTS...
What is the current status of trial NCT00006489?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 165 participants. The study started on 2000-12. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00006489?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG), Cognitive-Behavioral Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00006489?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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