NCT07734701Not yet recruitingPhase 2
Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder
Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- Oct 2026
- Primary completion date
- Mar 2031
- Lead sponsor
- Sherwood Brown, MD, PhD
- Diseases
- Depression
- NCT number
- NCT07734701
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From Oct 2026 to the primary completion date, Mar 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of medications or treatments that would interfere with study participation or interpretation of results.
Other illness
- 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.
Other
- Contraindications to magnetic resonance imaging (MRI).
- Current pregnancy or breastfeeding.
- Significant suicide risk requiring a higher level of care.
Who the study is looking for
- 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
Age in the registry: 21 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Texas at Dallas Coordinator of this site? Confirm its status | Richardson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.