Who is eligible for clinical trial NCT05223829?

Participants must meet protocol criteria for PTSD. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05223829 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-08

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder (NCT05223829)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Yale University

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (14 items).

Location: Yale School of Medicine — New Haven, Connecticut

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 21-55 years old
Meet DSM-5 diagnostic criteria for AUD within the past 6 months, as well as the following drinking criteria:
Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days
Women: drink greater than 7 drinks per week and exceed four drinks per day at least once per week within the past 30 days
Meet DSM-5 diagnostic criteria for PTSD in the past 6 months

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Actively seeking treatment for AUD
Likely to experience clinically significant alcohol withdrawal during the study procedures (e.g., history of alcohol-related perceptual distortions/hallucinations, seizures, or Clinical Institute Withdrawal Assessment Scale score \> 8 at intake)
Current (i.e., past month) active suicidal ideation and/or homicidal ideation
Meets DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses.
Meets criteria for current (past 6 months) substance use disorders (other than tobacco use disorder).
Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session
Is actively engaged in psychotherapy to treat PTSD
Any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP \>160/100 or \<90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV
Past 30 day use of psychoactive drugs including anxiolytics and antidepressants.
Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD)
Specific exclusions for the administration of brexanolone not already specified include: Individuals with end stage renal disease, treatment with any opioids or other CNS depressants, such as benzodiazepines.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Yale School of Medicine — New Haven, Connecticut

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗