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NCT00338962 · ClinicalTrials.gov registry record · Phase 3
Naltrexone & SSRI in Alcoholics With Depression/PTSD
A Phase 3 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
NCT00338962: Completed Phase 3 study, sponsored by Yale University.
NCT00338962 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 88 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00338962, a Phase 3 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
Primary Outcome
The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.
Interventions
- DRUG Placebo
- DRUG Naltrexone
- DRUG paroxetine
- DRUG desipramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2001-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT00338962 record still lists
NCT00338962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00338962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00338962 about?
NCT00338962 is a clinical study titled "Naltrexone & SSRI in Alcoholics With Depression/PTSD". The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption th...
What is the current status of trial NCT00338962?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2001-10. Estimated completion is 2015-07.
What interventions are being tested in trial NCT00338962?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG), paroxetine (DRUG), desipramine (DRUG).
Who is sponsoring clinical trial NCT00338962?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00338962's enrollment target sits among peer trials
88 1739th of 2000 higher than 259 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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