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NCT04015869 · ClinicalTrials.gov registry record · Phase 1
Effect of Allopregnanolone on Stress-induced Craving
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04015869: Completed Phase 1 study, sponsored by Yale University.
NCT04015869 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015869, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.
Primary Outcome
The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).
Interventions
- DRUG Placebos
- DRUG Allopregnanolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
What the finished NCT04015869 record still lists
NCT04015869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04015869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04015869 about?
NCT04015869 is a clinical study titled "Effect of Allopregnanolone on Stress-induced Craving". The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.
What is the current status of trial NCT04015869?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-07-01. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT04015869?
The interventions under investigation include: Placebos (DRUG), Allopregnanolone (DRUG).
Who is sponsoring clinical trial NCT04015869?
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 NCT04015869's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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