Pregnenolone for the Treatment of Alcohol Use Disorder

• Status: Not yet recruiting
• Trial end date: 2028-06-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University

Criteria

Inclusion Criteria:

• Male or female individuals, ages 18 to 70.

• Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.

• Subject has voluntarily given informed consent and signed the informed consent document.

• Able to read English and complete study evaluations.

Exclusion Criteria:

• Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.

• Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.

• Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).

• Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.

• Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.

• 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.

• Hypotensive individuals with sitting blood pressure below 90/50 mmHG.