Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

Part of paid clinical trials in Dallas, Texas.

Sponsor
Sherwood Brown, MD, PhD
Study ID
NCT07734701
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Pregnenolone — DRUG
    Pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.
  • Placebo — DRUG
    Matching placebo capsules administered twice daily for 12 weeks.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pregnenolone
    Participants will receive pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo capsules administered twice daily for 12 weeks.

Primary Outcome Measure

Alcohol Consumption [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
E. Sherwood Brown
[email protected]
214-645-6950
E. Sherwood Brown (PRINCIPAL_INVESTIGATOR)
University of Texas at DallasRichardsonTexas75080
Francesca Filbey
[email protected]
972-883-2313
Francesca Filbey (PRINCIPAL_INVESTIGATOR)

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UT Southwestern Medical Center· Dallas, TXUniversity of Texas at Dallas· Richardson, TX

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