Pregnenolone for the Treatment of Alcohol Use Disorder

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

In this Phase 2 single-site randomized controlled trial (RCT), men and women with Alcohol Use Disorder (AUD) will be enrolled in a 12 week trial with a 1-month follow-up assessment. Participants will be randomly assigned to 300mg pregnenolone (PREG) treatment b.i.d., or Placebo (PBO). All participants will be assessed 2x weekly and also receive behavior counseling to support recovery. The study aims to examine a) the safety and tolerability; b) efficacy on alcohol use outcomes; and c) effects on alcohol craving, anxiety, depression and physical well-being of 300mg PREG vs. PBO in men and women with AUD over the 12-week treatment period and at the 1-month follow up post-treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05781009
Study type	Interventional
Source	Yale University
Contact	Verica Milivojevic, PhD
Phone	203-737-1176
Email	verica.milivojevic@yale.edu
Status	Recruiting
Phase	Phase 2
Start date	January 8, 2024
Completion date	July 31, 2028

View Details

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