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

NCT06580444 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-31

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

Brexanolone

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • VA Connecticut Healthcare System

    collaborator FED

  • Sage Therapeutics

    collaborator INDUSTRY

  • RTI International

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

    lead OTHER

Principal Investigators

  • MacKenzie R. Peltier, Ph.D. · Assistant Professor Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2027-02-26
Completion
2027-03-19
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580444 on ClinicalTrials.gov