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NCT04596267 · ClinicalTrials.gov registry record · Phase 1
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
A Phase 1 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT04596267: Clinical Trial Phase 1 study, sponsored by Boston Medical Center.
NCT04596267 is a Phase 1 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596267, a Phase 1 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this proposal is to determine whether pitolisant has effects on alcohol consumption and craving
Primary Outcome
Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units (SDU). A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Lower SDUs are favorable.
Interventions
- DRUG Placebo
- DRUG Pitolisant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-09-13 |
| Est. Completion | 2023-02-03 |
| Phase | Phase 1 |
Why NCT04596267 stopped before completion
NCT04596267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04596267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596267 about?
NCT04596267 is a clinical study titled "Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers". This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this proposal is to determine whether pitolisant has effects on alcohol con...
What is the current status of trial NCT04596267?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2021-09-13. Estimated completion is 2023-02-03.
What interventions are being tested in trial NCT04596267?
The interventions under investigation include: Placebo (DRUG), Pitolisant (DRUG).
Who is sponsoring clinical trial NCT04596267?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596267's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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