Could a postpartum depression drug curb alcohol cravings in PTSD?
NCT ID NCT05223829
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests whether brexanolone, a drug already approved for postpartum depression, can safely reduce stress-induced alcohol use in 25 adults with both PTSD and alcohol use disorder. Participants receive a continuous 20-hour IV infusion under medical supervision. The main goal is to check safety and feasibility, not yet to prove effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brexanolone (Zulresso)
- What this could lead to
- If it works, this could point toward a new treatment option for people with both PTSD and alcohol use disorder.
- What could go wrong
- This is a very small, early-phase safety study with only 25 participants, so results may not apply widely. The drug is given as a 20-hour IV infusion under medical observation, which limits convenience.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Dec 2025
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 21-55 years old 4. Meet DSM-5 diagnostic criteria for AUD within the past 6 months, as well as the following drinking criteria: 1. Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days 2. Women: drink greater than 7 drinks per week and exceed four drinks per day at least once per week within the past 30 days 5. Meet DSM-5 diagnostic criteria for PTSD in the past 6 months Exclusion Criteria: 1. Actively seeking treatment for AUD 2. 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) 3. Current (i.e., past month) active suicidal ideation and/or homicidal ideation 4. Meets DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses. 5. Meets criteria for current (past 6 months) substance use disorders (other than tobacco use disorder). 6. Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session 7. Is actively engaged in psychotherapy to treat PTSD 8. 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 9. Past 30 day use of psychoactive drugs including anxiolytics and antidepressants. 10. 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) 11. 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. 12. Subjects likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments. 13. Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Yale School of Medicine
New Haven, Connecticut, 06519, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Brain-Training games rewire the mind to fight alcohol addiction?
- Can a Stress-Hormone blocker take the edge off alcohol?
- Can MDMA plus therapy help veterans fight both PTSD and alcohol addiction?
- Can a personalized mix of nerve stimulation and therapy rewire the brain for better mental health?
- Can a therapist on a screen ease both trauma and pain?
- Brain scans probe opioid receptor imbalance in alcohol use disorder