Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder (NCT07734701) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder
United States100 participantsStarted 2026-10
Plain-language 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.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.