Pregnenolone for the Treatment of Alcohol Use Disorder

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).

Key facts

Study ID

NCT05781009

Run by

Yale University

People needed

150

Starts

2024-01-08

Expected to finish

2028-07-31

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The Yale Stress Center: Yale University — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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