The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.
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.
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.
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.
Parallel
Brexanolone
DrugThe participant will receive either a placebo, or 90, 60, or 30 mcg/kg/hr of Brexanolone over a 20-hour period intravenous infusion.
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.
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).
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).
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).
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Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Lead sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
VA Connecticut Healthcare System
Collaborator
Sage Therapeutics
Collaborator
RTI International
Collaborator
Yale University
Collaborator
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