Using pregnenolone to treat Alcohol Use Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized controlled trial will evaluate the safety and efficacy of pregnenolone, administered at a dose of 300 mg twice daily, compared to a placebo over a 12-week period in individuals diagnosed with Alcohol Use Disorder (AUD). Participants will receive behavioral counseling and will be assessed twice weekly for alcohol use outcomes, cravings, anxiety, depression, and overall physical well-being. The study aims to determine the tolerability of pregnenolone and its potential benefits in reducing alcohol consumption and improving mental health symptoms associated with AUD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• The Yale Stress Center: Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Verica Milivojevic, PhD
• Email: verica.milivojevic@yale.edu
• Phone: 203-737-1176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.