Pregnenolone for adults with alcohol use disorder and major depression
Tests pregnenolone against placebo in adults with alcohol use disorder and depression.
Plain-language title generated from the registry record
Registry title: Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder
Key facts
- Where
- Dallas and Richardson, United StatesSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 55 years old?
Source: NCT07734701, who can take part
Where in United States
- UT Southwestern Medical CenterDallas, United StatesNo longer taking part
- University of Texas at DallasRichardson, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sherwood Brown, MD, PhD
- Trial code
- NCT07734701
- Record updated
- 24 August 2026
- Original description
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.Read full original descriptionShow less
Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy
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.
Inclusion: 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: Current use of medications or treatments that would interfere with study participation or interpretation of results; 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; Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity; Contraindications to magnetic resonance imaging (MRI); Current pregnancy or breastfeeding; Significant suicide risk requiring a higher level of care.