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

Alcohol Use Disorder Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

This project is a Phase 1 (open-label, single arm, proof of concept) laboratory design. It will investigate the feasibility and safety of administering brexanolone to men and women with PTSD/AUD. Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be administered brexanolone as a continuous IV infusion over 20 hours. Participants will be monitored during infusion by medical personnel. Forty-eight hours following drug administration, participants will then complete a laboratory session. During the laboratory session, personalized imagery (stress) will precede a 2 hour alcohol self-administration period. Subjects will then complete a follow-up period, including assessments of alcohol use, PTSD symptoms, and side effects weekly for the next 30 days. Primary outcome measures include treatment-emergent adverse events following administration of brexanolone for 30-days, as well as the percentage of milliliters consumed during ad-libitum drinking in the laboratory session. Additionally, at each visit the participants will complete a timeline follow-back assessment for a 30-day period (or the number of days in between intake, drug, and laboratory sessions) to explore a sustained reduction in in-vivo alcohol use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05223829
Study type Interventional
Source Yale University
Contact MacKenzie R Peltier, PhD
Phone 203-932-5711
Email mackenzie.peltier@yale.edu
Status Recruiting
Phase Phase 1
Start date August 1, 2023
Completion date April 30, 2024
View Details
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