Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05223829
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Brexanolone — DRUG
    Brexanolone will be administered as a continuous IV infusion over 20 hours under medical observation

Study Details

For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).

Key Dates

Start date
Aug 1, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brexanaolone
    In this single-arm study, participants will be administered brexanolone as a continuous IV infusion over 20 hours (titrated up to 90mcg/kg/hour).

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: 30 days following administration of brexanolone ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06519-

Find similar trials in New Haven, CT

By condition
Substance use disorderPTSD (post-traumatic stress disorder)
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
Yale School of Medicine· New Haven, CT

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