Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study

Sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Study ID
NCT06580444
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Alcohol Use Disorder (AUD)
  • Post Traumatic Stress Disorder (PTSD)

Eligibility Criteria

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

Interventions

  • Brexanolone — DRUG
    The participant will receive either a placebo, or 90, 60, or 30 mcg/kg/hr of Brexanolone over a 20-hour period intravenous infusion.

Study Details

The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.

Key Dates

Start date
Jul 28, 2025
Status verified
May 2025
Primary completion
Feb 26, 2027
Completion
Mar 19, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Placebo
    A 0.9% bag of sodium chloride will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
  • Active Comparator: 90mcg/kg/h dose of Brexanolone
    Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
  • Active Comparator: 60mcg/kg/h dose of Brexanolone
    Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
  • Active Comparator: 30mcg/kg/h dose of Brexanolone
    Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.

Primary Outcome Measure

Severity and numbers of treatment-emergent AEs [ Time Frame: From onset of Brexanolone administration until 30-day follow up. ]

Central Contacts

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