Yale University
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).
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…
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 sever…
300mg
placebo
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