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Pregnenolone for Alcohol Use Disorder and Major Depressive Disorder

This study is testing if pregnenolone (a natural steroid) can help adults who have both Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). You would be randomly assigned to receive either pregnenolone (500 mg/day) or a placebo (an inactive pill) for 12 weeks. Researchers will look at how much alcohol you drink, your cravings, and your depression and anxiety symptoms. They will also use MRI scans to see how pregnenolone affects brain areas linked to addiction and mood. The goal is to see if pregnenolone can improve both alcohol use and mood, and how it works in the brain. The study plans to enroll about 100 participants, but its current status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning you would be randomly assigned to pregnenolone or placebo, and neither you nor the researchers would know which you are receiving. It plans to enroll about 100 adults.
What's involved
You would take pregnenolone or placebo twice daily for 12 weeks. Clinical assessments would be done throughout this period, and MRI scans would be taken at the beginning and end of the 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring alcohol consumption is at Week 12, which is the end of the treatment period.

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NCT07734701

Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

Not Yet Recruiting
PHASE2Ages 21–55InterventionalTreatment
Sherwood Brown, MD, PhD
~100 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:PregnenolonePlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alcohol Consumption
Measured over Baseline to Week 12

Conditions

Alcohol Use Disorder (AUD)
Major Depressive Disorder (MDD)

Explore related trials

Alcohol use disorderUnipolar Depression

Where it's being run

2 sites across 1 states
Texas2

Who to contact

E. Sherwood Brown
[email protected]
214-645-6950
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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.

What this trial measures

  • Alcohol ConsumptionBaseline to Week 12

    Change in alcohol consumption from baseline to Week 12. The timeline follow-back (TLFB) is a semi-structured interview method assessing recent drinking in which participants retrospectively estimate daily quantity of alcohol consumption during specified time periods. The TLFB will be used to assess alcohol use including drinks/drinking day and drinks/day (7-day average).