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Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

NCT07734701 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-29

No results posted yet for this study

Summary

This study will evaluate whether pregnenolone is an effective treatment for adults with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study. Researchers will assess alcohol consumption, alcohol craving, depressive symptoms, and anxiety symptoms throughout treatment. The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation. The goal is to determine whether pregnenolone can improve both alcohol-related and mood-related outcomes and to identify the neural mechanisms associated with treatment response.

Conditions

  • Alcohol Use Disorder (AUD)
  • Major Depressive Disorder (MDD)

Interventions

DRUG

Pregnenolone

Pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.

DRUG

Placebo

Matching placebo capsules administered twice daily for 12 weeks.

Sponsors & Collaborators

  • The University of Texas at Dallas

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Sherwood Brown, MD, PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2031-03-31
Completion
2031-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734701 on ClinicalTrials.gov