A Phase 2 interventional study of Brexanolone in Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. Not yet recruiting. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Phase 2, Interventional, and Other
The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.
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:
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 40 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Pharmacotherapies for Alcohol and Substance Use Disorders Alliance is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Current diagnostic criteria for AUD (mild, moderate, or severe) within 6 months at the time of the intake, as measured via Quick Structured Clinical Interview for DSM-5 (QuickSCID-5), as well as the following drinking criteria (measured by the Timeline Followback):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0.9% bag of sodium chloride will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
Drug: Brexanolone
Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
Drug: Brexanolone
Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking.
Drug: Brexanolone
The participant will receive either a placebo, or 90, 60, or 30 mcg/kg/hr of Brexanolone over a 20-hour period intravenous infusion.
Also known as: Placebo
Severity and numbers of treatment-emergent AEs
The number and proportion of individuals experiencing any adverse event, any SAE, and any related adverse event overall will be summarized using frequency tables. No formal statistical tests will be conducted, rather the safety will be evaluated from a risk/benefit perspective. Any p-values reported will be for descriptive purposes only.
Time frame: From onset of Brexanolone administration until 30-day follow up.
Change in Heart Rate from onset of Brexanolone administration until discharge from the drug administration session.
The change in heart rate a physiological safety/stress measure are continuous and obtained multiple times after study drug administration which occurs on day 1. This measure will be analyzed using descriptive statistics and graphical summaries including time-specific summary statistics (e.g., box and whisker plots).
Time frame: An average of 22 hours (From the start of Brexanolone administration on day 1 at 10 am until 7 am on day 2)
Change in Blood Pressure from onset of Brexanolone administration until discharge from the drug administration session.
The change in blood pressure a physiological safety/stress measure are continuous and obtained multiple times after study drug administration which occurs on day 2. This measure will be analyzed using descriptive statistics and graphical summaries including time-specific summary statistics (e.g., box and whisker plots).
Time frame: An average of 22 hours (From the start of Brexanolone administration on day 1 at 10 am until 7 am on day 2)
Change in Cortisol from onset of Brexanolone administration until discharge from the drug administration session.
The change in Cortisol a physiological safety/stress measure are continuous and obtained multiple times after study drug administration which occurs on day 2. This measure will be analyzed using descriptive statistics and graphical summaries including time-specific summary statistics (e.g., box and whisker plots).
Time frame: FAn average of 22 hours (From the start of Brexanolone administration on day 1 at 10 am until 7 am on day 2)
Change in percentage of milliliters of alcohol consumed during the 2-hour ad-libitum drinking paradigm between laboratory sessions (stress vs. neutral).
A set of dose-response models will be tested response using the Multiple Comparisons Procedure Modifications (MCP-Mod) methodology including change in percentage of milliliters consumed during the 2-hour ad-libitum drinking paradigm within laboratory sessions (stress and neutral) as dependent variable, the treatment as factor (90, 60, 30 and 0 mcg/kg/h), and baseline dependent value. These dose-response models with repeated measures will be used to test the effects of the regimens of 90, 60, and 30 mcg/kg/h doses of brexanolone on alcohol consumption in self-administration.
Time frame: During the 2-hour ad-libitum drinking paradigm between lab sessions (stress Vs Neutral)
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score from intake until 30-day follow-up
Another set of dose-response models will test Multiple Comparisons Procedure Modifications (MCP-Mod) methodology for the 30-day follow-up in PCL-5 score as dependent variable, the treatment as factor (90, 60, 30 and 0 mcg/kg/h), and baseline dependent value. These dose-response models will be used to test the effects of the regimens of 90, 60, 30 and 0 mcg/kg/h doses of brexanolone on PTSD symptoms. Scale PCL-5 is 0-4 with 0 being not at all and 4 being extreme; the higher score is worse outcome
Time frame: From intake, day 0 through day 37 (30-day follow-up).
Change in Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score from intake until end of dosing.
Another set of dose-response models will test Multiple Comparisons Procedure Modifications (MCP-Mod) methodology including change from intake to end of dosing in PCL-5 score as dependent variable, the treatment as factor (90, 60, 30 and 0 mcg/kg/h), and baseline dependent value. The same modeling will be repeated for the 30-day follow-up timepoint. These dose-response models will be used to test the effects of the regimens of 90, 60, 30 and 0 mcg/kg/h doses of brexanolone on PTSD symptoms. Scale PCL-5 is 0-4 with 0 being not at all and 4 being extreme; the higher score is worse outcome
Time frame: An average of 22 hours (From intake, day 0 through end of infusion on Day 2)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Brexanolone
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance