Pregnenolone to treat alcohol use disorder
Pregnenolone for the Treatment of Alcohol Use Disorder
['FUNDING_R01'] · YALE UNIVERSITY · NIH-11138706
People with alcohol use disorder are randomly given a daily pregnenolone pill or a placebo for 12 weeks to see whether it lowers cravings, anxiety, and drinking.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | YALE UNIVERSITY (nih funded) |
| Locations | 1 site (NEW HAVEN, UNITED STATES) |
| Trial ID | NIH-11138706 on ClinicalTrials.gov |
What this research studies
You would be randomly assigned to take 300 mg/day of pregnenolone or a matching placebo for 12 weeks without knowing which one you get. The trial is double-blind and will enroll about 150 men and women with alcohol use disorder, with study visits during treatment and a one-month follow up. Researchers will track drinking (heavy drinking days, percent drinking days, average drinks per day), craving, anxiety, safety, and stress-related biological measures. This builds on an earlier 8-week pilot that found pregnenolone reduced stress- and cue-induced craving, anxiety, and drinking compared with placebo.
Who could benefit from this research
Good fit: Adults with diagnosed alcohol use disorder who are medically stable, can take study medication, and can attend visits at Yale are the intended participants.
Not a fit: People without alcohol use disorder, pregnant or breastfeeding individuals, those with certain medical conditions or contraindicated medications, or those unable to travel to Yale are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, pregnenolone could reduce alcohol craving and heavy drinking and help prevent relapse in people with alcohol use disorder.
How similar studies have performed: A prior human laboratory study and an 8-week pilot clinical trial showed promising reductions in craving, anxiety, and drinking with pregnenolone, but larger randomized trials are needed to confirm benefits.
Where this research is happening
NEW HAVEN, UNITED STATES
- YALE UNIVERSITY — NEW HAVEN, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: MILIVOJEVIC, VERICA — YALE UNIVERSITY
- Study coordinator: MILIVOJEVIC, VERICA
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.