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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). 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.
Primary Outcome
The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
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 |
What the finished NCT00006489 record still lists
NCT00006489 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00006489 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00006489's enrollment target sits among peer trials
165 492nd of 2000 higher than 1,505 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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