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NCT05781009 · ClinicalTrials.gov registry record · Phase 2
Pregnenolone for the Treatment of Alcohol Use Disorder
A Phase 2 study of Alcohol Use Disorder, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05781009: Recruiting Phase 2 study of Alcohol Use Disorder, sponsored by Yale University.
NCT05781009 is a Phase 2 study of Alcohol Use Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 150 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05781009, a Phase 2 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).
Primary Outcome
Pregnenolone versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pregnenolone
Study Locations (1)
Connecticut
- The Yale Stress Center: Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT05781009 shows while recruiting
NCT05781009 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05781009 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05781009 about?
NCT05781009 is a clinical study titled "Pregnenolone for the Treatment of Alcohol Use Disorder". This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).
What is the current status of trial NCT05781009?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-01-08. Estimated completion is 2028-07-31.
What conditions does trial NCT05781009 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT05781009?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT05781009?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05781009 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05781009's enrollment target sits among peer trials
150 62nd of 184 higher than 119 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder 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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