Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder | NCT07734701

NCT07734701

Overview

NCT ID: NCT07734701
Lead Sponsor: Sherwood Brown, MD, PhDOTHER
Official Title: Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy
Brief 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)

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 21 to 55 years.

Meets DSM-5 criteria for Alcohol Use Disorder (AUD).

Meets DSM-5 criteria for Major Depressive Disorder (MDD).

Able to provide informed consent.

Willing and able to comply with study procedures and assessments

Exclusion Criteria:

Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder.

Current substance use disorder requiring immediate treatment other than alcohol or nicotine.

Significant unstable medical or neurologic illness that would interfere with participation or study assessments.

Contraindications to magnetic resonance imaging (MRI).

Current pregnancy or breastfeeding.

Current use of medications or treatments that would interfere with study participation or interpretation of results.

Significant suicide risk requiring a higher level of care.

Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity.

Central Contacts: E. Sherwood BrownContact
SHERWOOD.BROWN@UTSouthwestern.edu214-645-6950