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NCT00817089 · ClinicalTrials.gov registry record · Phase 4
Understanding Treatment Response With Naltrexone Among White Alcoholics
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00817089: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00817089 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00817089, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcohol dependence and treatment by defining an endophenotype associated with treatment response. The study consists of two inpatient alcohol challenge sessions with treatment using random assignment to either naltrexone or placebo.
Primary Outcome
Change from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood. Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes.
Interventions
- DRUG Placebo Oral Tablet
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00817089 record still lists
NCT00817089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT00817089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00817089 about?
NCT00817089 is a clinical study titled "Understanding Treatment Response With Naltrexone Among White Alcoholics". This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcohol dependence and treatment by defining an endophenotype associated with treatment response. The stud...
What is the current status of trial NCT00817089?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2007-12. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00817089?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT00817089?
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 NCT00817089's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 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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