Overview

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

Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sage Therapeutics
Treatments:
Brexanolone
Criteria
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