Clinical TrialID 8402
Pregnenolone for the Treatment of Alcohol Use Disorder
NCT05781009
Alcohol Use Disorder
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8402
- Evidence Id
- 8402
- Core Evidence Id
- 8402
- Source Clinical Trial Id
- 8400
- Herb2 Clinical Trial Id
- HBCT008400
- Nct Id
- NCT05781009
- Title
- Pregnenolone for the Treatment of Alcohol Use Disorder
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Alcohol Use Disorder
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Pregnenolone|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 150
- Outcome Measure
- Percent of Subjects with no Heavy Drinking Days, Pregnenolone versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period., 12 weeks|Safety of pregnenolone, The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial., 12 weeks
- Sponsor Collaborator
- Yale University|National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Funded By
- OTHER
- Location
- The Yale Stress Center: Yale University, New Haven, Connecticut, 06519, United States
- Other Id
- 2000034929|1R01AA030923-01
- Start Date
- 2024-01-08
- Primary Completion Date
- 2028-07-31
- Completion Date
- 2028-07-31
- First Posted
- 2023-03-23
- Results First Posted
- Last Update Posted
- 2024-06-11
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05781009
- Title Cn
- Title En
- Pregnenolone for the Treatment of Alcohol Use Disorder
- Bilingual Status
- semi_complete