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NOT YET RECRUITING
NCT07734701
PHASE2

Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

Sponsor: Sherwood Brown, MD, PhD

View on ClinicalTrials.gov

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.

Official title: Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy

Key Details

Gender

All

Age Range

21 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10

Completion Date

2031-03

Last Updated

2026-07-29

Healthy Volunteers

No

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.

Locations (2)

UT Southwestern Medical Center

Dallas, Texas, United States

University of Texas at Dallas

Richardson, Texas, United States