At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 91 enrolled
Drug / intervention
Pregnenolone300 +2 moredrug
Likely dose
Pregnenolone 300 mg or 500 mgAI-extracted
Key inclusion· 3
- ✓Males or females, ages 18 to 68
- ✓Meet current DSM-5 criteria for alcohol use disorder with documented positive urine toxicology or collateral report of recent use
- ✓Able to read English and complete study evaluations
Key exclusion· 7
- ✕Pregnant, nursing, or women of childbearing potential not using effective birth control
- ✕Current use disorder for another psychoactive substance (heroin, amphetamines, hallucinogens/PCP), excluding alcohol and nicotine
- ✕Current or past opiate use or use disorder
- ✕Current use of psychoactive drugs including anxiolytics, naltrexone, or antabuse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
In Brief
A Phase 1 clinical trial evaluating Pregnenolone300, Pregnenolone500, and 1 other intervention for Alcohol Use Disorder. Completed, enrolled 91 participants across 2 sites.
Detailed Summary
To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with alcohol use disorder (AUD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartSep 2018
First PostedMar 2019
Primary CompletionNov 2022
Study CompletionAug 2023
TodayJul 2026
First PostedMar 13, 2019
Enrollment StartSep 27, 2018
Primary CompletionNov 1, 2022
Study CompletionAug 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.3 years ago
Interventions
Pregnenolone300drug
300mg
Pregnenolone500drug
500mg
Placebodrug
placebo