Pregnenolone for the Treatment of Alcohol Use Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05781009
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pregnenolone — DRUG
    300mg
  • Placebo — DRUG
    placebo

Study Details

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).

Key Dates

Start date
Jan 8, 2024
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: patients receiving 300mg PREG
    Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
  • Placebo Comparator: placebo
    Patients randomly assigned to receive a placebo daily.

Primary Outcome Measure

Percent of Subjects with no Heavy Drinking Days [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Yale Stress Center: Yale UniversityNew HavenConnecticut06519
Rachel Hart, MS
[email protected]
203-737-4791
Verica Milivojevic, PhD
[email protected]
12037371176
Verica Milivojevic, PhD (PRINCIPAL_INVESTIGATOR)
Rajita Sinha, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
The Yale Stress Center: Yale University· New Haven, CT

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