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Pregnenolone for Alcohol Use Disorder

This study is testing a drug called pregnenolone (300mg) against a placebo (an inactive substance) to see if it can help people with Alcohol Use Disorder (AUD). Researchers want to find out if pregnenolone is safe and effective in reducing heavy drinking. You might be able to join if you are between 18 and 70 years old, have moderate to severe AUD, and drink alcohol at least three times a week. The main goal is to see what percentage of people have no heavy drinking days after 12 weeks, and to check the safety of pregnenolone. The study status is currently unclear.

Study design
This is a Phase 2 randomized controlled trial. About 150 participants will be randomly assigned to receive either pregnenolone or a placebo.
What's involved
You would participate in a 12-week treatment period, with assessments twice a week and behavioral counseling. There will also be a 1-month follow-up after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 1-month follow-up assessment after the 12-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05781009

Pregnenolone for the Treatment of Alcohol Use Disorder

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Yale University
~150 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:PregnenolonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of Subjects with no Heavy Drinking Days
Measured over 12 weeks
+1 more outcome measured

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Connecticut1

Who to contact

Verica Milivojevic, PhD
[email protected]
203-737-1176
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male and females, aged 18-70 years;
Regular weekly use of alcohol at least 3X weekly or more at treatment entry;
Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-5;
No health conditions that would impact trial participation as verified by screening and physical examination and absence of any of the exclusion criterions outlined below;
Able to read English and complete study evaluations;
Able to provide informed written and verbal consent.

Exclusion

Meet current criteria for moderate to severe substance use disorders from use of any other psychoactive substance, excluding nicotine and cannabis use disorder;
Current use of opioids;
Regular use of anticonvulsants, sedatives or hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), topiramate, baclofen;
Regular use of steroidal supplements and steroid medications interacting with study medications based on clinical judgement of study physician (excluding hormonal contraceptives in women);
Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study, but stable, prescribed anti-hypertensives. cardiovascular and diabetes medications will be allowed after review by study physician;
Any psychotic disorder or current Axis I psychiatric disorders requiring specific acute attention, including need for psychiatric medications, but stable, prescribed antidepressants and anti-anxiety medication to treat co-occurring psychiatric disorders will be allowed;
Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by urine pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).

What this trial measures

  • Percent of Subjects with no Heavy Drinking Days12 weeks

    Pregnenolone versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.

  • Safety of pregnenolone12 weeks

    The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.