Could a brain hormone curb alcohol cravings and lift depression at the same time?
NCT ID NCT07734701
First seen Jul 29, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This trial tests whether pregnenolone, a natural hormone, can help adults with both alcohol use disorder and major depression. Participants take either pregnenolone or a placebo for 12 weeks, while researchers track drinking, cravings, and mood. Brain scans will also look at how the treatment affects circuits linked to addiction and emotion.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pregnenolone
- What this could lead to
- If it works, this could point toward a new treatment option for people struggling with both alcohol use disorder and depression.
- What could go wrong
- This is a mid-stage trial with 100 participants, so results may not apply to everyone. Pregnenolone is a hormone and may cause side effects; its effectiveness for this dual condition is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Texas at Dallas
Richardson, Texas, 75080, United States
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