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