NCT06580444

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The overall objectives of this study are to establish the safety of administering 90, 60, and 30mcg/kg/h target doses of brexanolone (BREX; 20-hour infusion; versus placebo) and investigate efficacy of each dose to reduce PTSD symptoms, alcohol consumption, and stress reactivity via mood-induction paradigms in individuals with PTSD/AUD. The primary aims of this study are to: 1. Evaluate the safety and tolerability of BREX 90, 60, and 30 mcg/kg/h among individuals with PTSD/AUD 2. Investigate the medication effect of the 90, 60, and 30 mcg/kg/h doses of BREX to reduce alcohol consumption and PTSD symptoms in men and women with PTSD/AUD. The secondary aim of this study is to: 1\. Investigate the medication effect of each of the 90, 60, 30 mcg/kg/h doses of BREX to reduce stress reactivity via mood-induction paradigm in men and women with PTSD/AUD. The exploratory aim of this study is to: 1\. Explore sex-specific responses to brexanolone's effect on PTSD and alcohol use among men and women with PTSD/AUD.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-28
• Primary completion: 2027-02-26
• Completion: 2027-03-19
• First posted: 2024-08-30
• Last updated: 2025-05-31

Regulatory

• FDA-regulated drug study