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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 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.

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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).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Pregnenolone

Study Locations (1)

Connecticut

  • The Yale Stress Center: Yale University - New Haven

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-01-08
Est. Completion 2028-07-31
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT05781009

The ClinicalTrials.gov registry entry for NCT05781009 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (54% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.