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NCT00256451 · ClinicalTrials.gov registry record · Phase 4
Endophenotype for Alcohol Misuse in Healthy Minority Populations
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT00256451: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00256451 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256451, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.
Primary Outcome
Change from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.
Interventions
- DRUG placebo
- DRUG Naltrexone
- OTHER alcohol
- OTHER Sham alcohol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
What the finished NCT00256451 record still lists
NCT00256451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00256451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256451 about?
NCT00256451 is a clinical study titled "Endophenotype for Alcohol Misuse in Healthy Minority Populations". The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approv...
What is the current status of trial NCT00256451?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2005-11. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00256451?
The interventions under investigation include: placebo (DRUG), Naltrexone (DRUG), alcohol (OTHER), Sham alcohol (OTHER).
Who is sponsoring clinical trial NCT00256451?
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 NCT00256451's enrollment target sits among peer trials
43 1371st of 2000 higher than 621 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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