Using pregnenolone to treat Alcohol Use Disorder

Pregnenolone for the Treatment of Alcohol Use Disorder

This study is testing if taking pregnenolone can help people with Alcohol Use Disorder drink less and feel better mentally over 12 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT05781009 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18-70 who meet DSM-5 criteria for moderate to severe Alcohol Use Disorder and consume alcohol regularly.

Not a fit: Patients with other substance use disorders or those currently using opioids or certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals struggling with Alcohol Use Disorder.

How similar studies have performed: While the use of pregnenolone for AUD is a novel approach, previous studies on similar interventions have shown varying degrees of success.

Eligibility criteria

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 this trial is running

New Haven, Connecticut

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

Study contacts

• Study coordinator: Verica Milivojevic, PhD

Conditions Alcohol Use Disorder