Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

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.

NCT Number	NCT07734701
Lead Sponsor	Sherwood Brown, MD, PhD Collaborators: The University of Texas at Dallas, Duke University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol Use Disorder (AUD), Major Depressive Disorder (MDD)
Enrollment	100 participants
Start Date	2026-10
Primary Completion	2031-03 (estimated)
Study Completion	2031-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-29