Alcohol Use Disorder (AUD)Phase 2NCT06580444
Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
A Phase 2 study testing Brexanolone in people with Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
Trial summary
The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Brexanolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 21-70 years old, either active duty or with a history of US military service.
- Current DSM-5 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):
- Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days at the time of intake.
- Women: drink greater than 7 drinks per week and exceed four drinks per day at least once per week within the past 30 days at the time of intake.
Show all 10Show fewer
- Men and women will not endorse a desire to completely abstain from alcohol use at any point during the study. It will be necessary to confirm, via self-report (TLFB), consumption of alcohol within the week prior to the alcohol laboratory sessions. In the event the TLFB indicates recent abstinence, participants will be explicitly queried regarding desire to completely abstain from alcohol use moving forward, utilizing a one question item. If a patient completes the drug administration session, but then endorses desire to abstain completely he/she will be followed via observation and not participate in laboratory sessions, in which alcohol is self-administered.
- Have a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥26 for the past month at intake, as well as a PTSD Checklist for DSM-5 (PCL-5) total score ≥31 for the past month at intake.
- Not currently taking medications thought to influence alcohol consumption such as Acamprosate, formulations of naltrexone, topiramate, ondansetron, baclofen, disulfiram, or gabapentin within 30 days prior to enrollment.
- Females of childbearing potential, who are not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for > 6 months) must be willing to use a medically acceptable and effective birth control method for at least 1 month prior to screening, randomization and intake and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills, patches, implants, injections, rings, diaphragm, intrauterine device (IUD), or condoms.
Who cannot join
- Meets current DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses, as defined by the QuickSCID-5 at intake. Please note that the QuickSCID-5 provides a Psychotic Symptom Screen. In the event, a patient screens positive for psychotic symptoms, the study team member will administer Modules B (Psychotic and Associated Symptoms) and C (Differential Diagnosis of Psychotic Disorders) from the Structured Clinician Interview for DSM-5 Clinician Version to determine a diagnosis of schizophrenia or another psychotic disorder.
- Increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and/or a current suicidal plan, per investigator's clinical judgement during interview.
- Treatment with trauma-focused therapy (e.g., Cognitive Processing Therapy, Prolonged Exposure Therapy, or Eye Movement Desensitization \& Reprocessing Therapy) for PTSD within two weeks of intake (if participant is receiving therapy, he/she must complete treatment prior to entering study). Note: Supportive psychotherapy in process at time of Screening may be continued.
- Meets criteria for current diagnosis of moderate or severe non-alcohol substance use disorder (except for caffeine and nicotine), as measured via QuickSCID-5, during the preceding 1 month relative to intake, per PI discretion, based on participant's screening interview.
- Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session. Patients who utilize cannabis but do not meet substance use disorder criteria are permitted.
- Self-reported past 30-day use at intake of psychoactive drugs (except cannabis), including opioids, CNS depressants (such as benzodiazepines), use of psychotropic medications in the class of antipsychotics, mood stabilizers, or stimulants. Note: Participant use of stable doses (prescribed for >2 months and the current dose has been stable or ≥3 weeks at intake) of antidepressants will be reviewed by Study MD.
Show all 10Show fewer
- 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, assessed during physical examination as part of intake procedures or b) have a score of > 8 on the Clinical Institute Withdrawal Assessment scale at intake appointment. Participants must have a CIWA-Ar score of < 8 prior to randomization.
- Any clinically significant, uncontrolled, or medical/surgical condition, that at the discretion of the investigator, would contraindicate use of brexanolone, or limit ability to complete study assessments, including end stage renal disease, significant arrhythmia or heart block, or heart failure, severe thrombocytopenia or hemophilia, severe hepatic failure, complete hearing loss, and/or need for surgery that might interfere with ability to participate. Such conditions will be assessed by the Study MD based upon physical examination (including review of medical history), as well as review of medical records, ECG and basic blood chemistries (i.e., CBC).
- Females who are pregnant, nursing, planning to become pregnant or fail to use one of the following methods of birth control during study participation (unless she or her partner is surgically sterile, or she is postmenopausal). Birth control includes: hormonal contraceptives (oral, implant, injection, patch, or ring), contraceptive sponge, double barrier (diaphragm or condom plus spermicide) or IUD.
- Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the study visit schedule or requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pregnenolone to Target Concurrent Posttraumatic Stress Disorder (PTSD) and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.
Read the detailed description
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:
- Evaluate the safety and tolerability of BREX 90, 60, and 30 mcg/kg/h among individuals with PTSD/AUD
- Investigate the medication effect of the 90, 60, and 30 mcg/kg/h doses of BREX to reduce alcohol consumption and PTSD symptoms in men and women with PTSD/AUD.
The secondary aim of this study is to:
- 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:
- Explore sex-specific responses to brexanolone's effect on PTSD and alcohol use among men and women with PTSD/AUD.
- Being tested
- Brexanolone
- Keywords
- Alcohol Used Disorder (AUD), Post Traumatic Stress Disorder (PTSD), Alcohol Use, Heavy Drinkers, Brexanolone
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexanoloneDrug
Also called Placebo
The participant will receive either a placebo, or 90, 60, or 30 mcg/kg/hr of Brexanolone over a 20-hour period intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | 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. |
| 90mcg/kg/h dose of Brexanolone | Active comparator | 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. Receives: Drug: Brexanolone |
| 60mcg/kg/h dose of Brexanolone | Active comparator | 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. Receives: Drug: Brexanolone |
| 30mcg/kg/h dose of Brexanolone | Active comparator | 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. Receives: Drug: Brexanolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: An average of 22 hours (From intake, day 0 through end of infusion on Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Jan 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At baseline, participants who meet eligibility criteria are randomized to placebo or 90, 60, or 30 mcg/kg/h doses of BREX along with the order/sequence of their stress and neutral lab sessions in a double-mask fashion for the duration of the study. The treatment allocation will be equal in each arm. Additionally, the order/sequence of stress and neutral laboratory sessions will be randomized for laboratory sessions (e.g., if stress on session #1 then neutral on session #2) in a manner that assures treatment balance within laboratory session. Each participant will be randomized to receive a target dose of either 90, 60, 30 and 0 mcg/kg/h, titrated over the 20 hours; both the 90 and 60 doses have shown efficacy to target postpartum depressive symptoms and the 30 mcg/kg/h will test the lower limits of efficacy. The sample size will have 10 participants in each group for doses 0, 30, 60 and 90 to equal 40 participants.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs, VA Connecticut Healthcare System, Sage Therapeutics, RTI International, Yale University
- Responsible party
- Sponsor
- Investigators
- MacKenzie R. Peltier, Ph.D., Principal investigator, Assistant Professor Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580444
- Sponsor's protocol ID
- AS210006-A09
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnenolone to Target Concurrent Posttraumatic Stress Disorder (PTSD) and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
- ClinicalTrials.gov ID
- NCT06580444
- Acronym / sponsor ID
- AS210006-A09
- Keywords
- Alcohol Used Disorder (AUD), Post Traumatic Stress Disorder (PTSD), Alcohol Use, Heavy Drinkers, Brexanolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders AllianceUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs, VA Connecticut Healthcare System, Sage Therapeutics, RTI International, Yale University
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.
Detailed description
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:
- Evaluate the safety and tolerability of BREX 90, 60, and 30 mcg/kg/h among individuals with PTSD/AUD
- Investigate the medication effect of the 90, 60, and 30 mcg/kg/h doses of BREX to reduce alcohol consumption and PTSD symptoms in men and women with PTSD/AUD.
The secondary aim of this study is to:
- 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:
- Explore sex-specific responses to brexanolone's effect on PTSD and alcohol use among men and women with PTSD/AUD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- At baseline, participants who meet eligibility criteria are randomized to placebo or 90, 60, or 30 mcg/kg/h doses of BREX along with the order/sequence of their stress and neutral lab sessions in a double-mask fashion for the duration of the study. The treatment allocation will be equal in each arm. Additionally, the order/sequence of stress and neutral laboratory sessions will be randomized for laboratory sessions (e.g., if stress on session #1 then neutral on session #2) in a manner that assures treatment balance within laboratory session. Each participant will be randomized to receive a target dose of either 90, 60, 30 and 0 mcg/kg/h, titrated over the 20 hours; both the 90 and 60 doses have shown efficacy to target postpartum depressive symptoms and the 30 mcg/kg/h will test the lower limits of efficacy. The sample size will have 10 participants in each group for doses 0, 30, 60 and 90 to equal 40 participants.
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –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. |
| 90mcg/kg/h dose of Brexanolone | Active comparator | Drug: BrexanoloneBrexanolone 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. |
| 60mcg/kg/h dose of Brexanolone | Active comparator | Drug: BrexanoloneBrexanolone 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. |
| 30mcg/kg/h dose of Brexanolone | Active comparator | Drug: BrexanoloneBrexanolone 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 21-70 years old, either active duty or with a history of US military service.
- Current DSM-5 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):
- Have a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥26 for the past month at intake, as well as a PTSD Checklist for DSM-5 (PCL-5) total score ≥31 for the past month at intake.
Key exclusion criteria (10 listed)
- Meets current DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses, as defined by the QuickSCID-5 at intake. Please note that the QuickSCID-5 provides a Psychotic Symptom Screen. In the event, a patient screens positive for psychotic symptoms, the study team member will administer Modules B (Psychotic and Associated Symptoms) and C (Differential Diagnosis of Psychotic Disorders) from the Structured Clinician Interview for DSM-5 Clinician Version to determine a diagnosis of schizophrenia or another psychotic disorder.
- Increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and/or a current suicidal plan, per investigator's clinical judgement during interview.
- Treatment with trauma-focused therapy (e.g., Cognitive Processing Therapy, Prolonged Exposure Therapy, or Eye Movement Desensitization \& Reprocessing Therapy) for PTSD within two weeks of intake (if participant is receiving therapy, he/she must complete treatment prior to entering study). Note: Supportive psychotherapy in process at time of Screening may be continued.
- Meets criteria for current diagnosis of moderate or severe non-alcohol substance use disorder (except for caffeine and nicotine), as measured via QuickSCID-5, during the preceding 1 month relative to intake, per PI discretion, based on participant's screening interview.
- Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session. Patients who utilize cannabis but do not meet substance use disorder criteria are permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexanoloneAlso: PlaceboThe participant will receive either a placebo, or 90, 60, or 30 mcg/kg/hr of Brexanolone over a 20-hour period intravenous infusion. | Drug | 30mcg/kg/h dose of Brexanolone, 60mcg/kg/h dose of Brexanolone, 90mcg/kg/h dose of Brexanolone |
Primary outcome
Severity and numbers of treatment-emergent AEs
Time frame: From onset of Brexanolone administration until 30-day follow up.
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.
Change in Heart Rate from onset of Brexanolone administration until discharge from the drug administration session.
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)
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).
Change in Blood Pressure from onset of Brexanolone administration until discharge from the drug administration session.
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)
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).
Change in Cortisol from onset of Brexanolone administration until discharge from the drug administration session.
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)
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).
Change in percentage of milliliters of alcohol consumed during the 2-hour ad-libitum drinking paradigm between laboratory sessions (stress vs. neutral).
Time frame: During the 2-hour ad-libitum drinking paradigm between lab 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.
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score from intake until 30-day follow-up
Time frame: From intake, day 0 through day 37 (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
Change in Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score from intake until end of dosing.
Time frame: An average of 22 hours (From intake, day 0 through end of infusion on Day 2)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- PASA WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder (AUD)
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MacKenzie R. Peltier, Ph.D. principal investigator
Assistant Professor Psychiatry
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brexanolone in people with Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assistant Professor Psychiatry (203-932-5711 ext. 13160, mackenzie.peltier@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and numbers of treatment-emergent AEs (time frame: From onset of Brexanolone administration until 30-day follow up.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.