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Neurosteroid

Brexanolone for PTSD

Phase 1

Recruiting

Led By MacKenzie R Peltier, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet DSM-5 diagnostic criteria for PTSD in the past 6 months

Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days following administration of brexanolone

Awards & highlights

Study Summary

This trial will study whether it is safe to give brexanolone to people who have both PTSD and AUD.

Who is the study for?

This trial is for adults aged 21-55 with PTSD and AUD who drink heavily but don't have severe mental illnesses, other substance use disorders (except tobacco), or are using psychoactive drugs. Pregnant/nursing women or those not on birth control are excluded, as well as anyone with serious health issues like heart problems, liver disease, seizures, or seeking AUD treatment.Check my eligibility

What is being tested?

The study tests the safety and feasibility of Brexanolone in individuals with PTSD and AUD. It aims to see if this medication can reduce stress-induced alcohol consumption among men and women meeting specific drinking criteria related to their conditions.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects of Brexanolone may include dizziness, sleepiness, dry mouth or changes in mood. Participants will be monitored for any adverse reactions due to the drug's interaction with alcohol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PTSD in the last 6 months.

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I am a man who drinks more than 14 times a week and has more than 5 drinks at least once a week.

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I am a woman who drinks more than 7 times a week and exceeds 4 drinks at least once a week.

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I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days following administration of brexanolone

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days following administration of brexanolone

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days following administration of brexanolone for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment-emergent adverse events

Side effects data

From 2021 Phase 3 trial • 28 Patients • NCT03665038

25%

Infusion site pain

13%

Nausea

13%

Upper respiratory tract infection

13%

Sedation

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Phase: Placebo

Double-Blind Phase: Brexanolone

Open-Label Phase: Brexanolone

Trial Design

1Treatment groups

Experimental Treatment

Group I: BrexanaoloneExperimental Treatment1 Intervention

In this single-arm study, participants will be administered brexanolone as a continuous IV infusion over 20 hours (titrated up to 90mcg/kg/hour).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brexanolone

2018

Completed Phase 3

~40

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,416 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,260 Total Patients Enrolled

Sage TherapeuticsIndustry Sponsor

49 Previous Clinical Trials

11,736 Total Patients Enrolled

Media Library

Brexanolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05223829 — Phase 1

Post-Traumatic Stress Disorder Research Study Groups: Brexanaolone

Post-Traumatic Stress Disorder Clinical Trial 2023: Brexanolone Highlights & Side Effects. Trial Name: NCT05223829 — Phase 1

Brexanolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223829 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Brexanolone been given the necessary governmental clearance for use with patients?

"Brexanolone has undergone limited testing, so it was assessed at a score of 1 in terms of safety and efficacy."

Answered by AI

Does this trial consider elderly individuals as potential participants?

"The age requirements for this trial are between 21 and 55 years old. There are 78 studies available to those under the legal minimum, while 560 studies target participants over pensionable age."

Answered by AI

Who is eligible to participate in this research endeavor?

"This medical trial is searching for 25 volunteers between the ages of 21 and 55 who habitually consume alcohol. Candidates must provide a signed informed consent, commit to all study requirements, be male or female, drink more than 14 drinks/week (men) and 7 drinks/week (women), with at least one occasion of consuming 5+ beverages in 24 hours during the past 30 days and demonstrate signs of PTSD according to DSM-5 criteria over the last six months."

Answered by AI

Are there still available slots for participants in this research experiment?

"Confirmed. Data on clinicaltrials.gov shows that this trial, initially posted in November 1st 2022 and updated recently on September 13th 2022, is no longer recruiting participants; however there are presently 759 other medical studies searching for patients to join them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mackenzie Peltier 2023. "Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05223829.

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