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Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder
Sponsor: Sherwood Brown, MD, PhD
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
Pregnenolone
Pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.
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