Pregnenolone for the Treatment of Alcohol Use Disorder
Trial Parameters
Eligibility Fast-Check
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Brief 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).
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