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

Primary Purpose

PTSD, Alcohol Use Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brexanolone
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring alcohol, brexanolone, PTSD

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brexanaolone

Arm Description

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

Outcomes

Primary Outcome Measures

Treatment-emergent adverse events
Treatment-emergent adverse events will be assessed following administration of brexanolone.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2022
Last Updated
October 12, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05223829
Brief Title
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
Official Title
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).
Detailed Description
This project is a Phase 1 (open-label, single arm, proof of concept) laboratory design. It will investigate the feasibility and safety of administering brexanolone to men and women with PTSD/AUD. Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be administered brexanolone as a continuous IV infusion over 20 hours. Participants will be monitored during infusion by medical personnel. Forty-eight hours following drug administration, participants will then complete a laboratory session. During the laboratory session, personalized imagery (stress) will precede a 2 hour alcohol self-administration period. Subjects will then complete a follow-up period, including assessments of alcohol use, PTSD symptoms, and side effects weekly for the next 30 days. Primary outcome measures include treatment-emergent adverse events following administration of brexanolone for 30-days, as well as the percentage of milliliters consumed during ad-libitum drinking in the laboratory session. Additionally, at each visit the participants will complete a timeline follow-back assessment for a 30-day period (or the number of days in between intake, drug, and laboratory sessions) to explore a sustained reduction in in-vivo alcohol use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Alcohol Use Disorder
Keywords
alcohol, brexanolone, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This project is a Phase 1 (open-label, single arm, proof of concept) laboratory design. It will investigate the feasibility and safety of administering brexanolone to men and women and collect preliminary data to understand brexanolone's efficacy to reduce stress-induced drinking in individuals with PTSD/AUD.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brexanaolone
Arm Type
Experimental
Arm Description
In this single-arm study, participants will be administered brexanolone as a continuous IV infusion over 20 hours (titrated up to 90mcg/kg/hour).
Intervention Type
Drug
Intervention Name(s)
Brexanolone
Other Intervention Name(s)
Zulresso
Intervention Description
Brexanolone will be administered as a continuous IV infusion over 20 hours under medical observation
Primary Outcome Measure Information:
Title
Treatment-emergent adverse events
Description
Treatment-emergent adverse events will be assessed following administration of brexanolone.
Time Frame
30 days following administration of brexanolone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 21-55 years old Meet DSM-5 diagnostic criteria for AUD within the past 6 months, as well as the following drinking criteria: Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days Women: drink greater than 7 drinks per week and exceed four drinks per day at least once per week within the past 30 days Meet DSM-5 diagnostic criteria for PTSD in the past 6 months Exclusion Criteria: Actively seeking treatment for AUD 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) Current (i.e., past month) active suicidal ideation and/or homicidal ideation Meets DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses. Meets criteria for current (past 6 months) substance use disorders (other than tobacco use disorder). Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session Is actively engaged in psychotherapy to treat PTSD 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 Past 30 day use of psychoactive drugs including anxiolytics and antidepressants. 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) 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. 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MacKenzie R Peltier, PhD
Phone
203-932-5711
Ext
3160
Email
mackenzie.peltier@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meaghan Lavery
Phone
203-737-2783
Email
meaghan.lavery@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MacKenzie R Peltier, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MacKenzie R Peltier, PhD
Phone
203-932-5711
Ext
3160
Email
mackenzie.peltier@yale.edu
First Name & Middle Initial & Last Name & Degree
MacKenzie R Peltier, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

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

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