Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy
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.
Description
Alcohol Use Disorder (AUD) commonly co-occurs with Major Depressive Disorder (MDD), resulting in substantial morbidity and limited treatment success. Pregnenolone is an endogenous neurosteroid that has demonstrated potential therapeutic effects on alcohol use, craving, mood symptoms, and neural pathways implicated in addiction and depression. This randomized, double-blind, placebo-controlled trial will enroll approximately 100 adults aged 21 to 55 years with DSM-5 diagnoses of AUD and MDD. Participants will be randomized to receive pregnenolone 500 mg/day (250 mg twice daily) or matched place…
Eligibility
- Age range
- 21–55 years
- Sex
- All
- Healthy volunteers
- No
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. * Co…
Interventions
- DrugPregnenolone
Pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.
- DrugPlacebo
Matching placebo capsules administered twice daily for 12 weeks.
Locations (2)
- UT Southwestern Medical CenterDallas, Texas
- University of Texas at DallasRichardson, Texas