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Could a postpartum depression drug curb alcohol cravings in PTSD?

NCT ID NCT05223829

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.