ACTIVE_NOT_RECRUITING

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

Conditions

PTSD Alcohol Use Disorder alcohol brexanolone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-08-01

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05223829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

MacKenzie R Peltier, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale School of Medicine

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

MacKenzie R Peltier, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

alcohol
brexanolone
PTSD

Additional Relevant MeSH Terms

PTSD
Alcohol Use Disorder