Using brexanolone to reduce alcohol use in people with PTSD
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
This study is testing if a new drug called brexanolone can help people with PTSD and alcohol problems reduce their drinking and improve their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05223829 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial aims to assess the feasibility and safety of brexanolone, an investigational drug, in individuals diagnosed with both Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). Participants will receive a continuous intravenous infusion of brexanolone over 20 hours, followed by a laboratory session where they will be exposed to personalized stress imagery and allowed to self-administer alcohol. The study will monitor participants for 30 days post-infusion to evaluate alcohol consumption, PTSD symptoms, and any side effects. This research seeks to gather pilot data that could inform future studies on the treatment of co-occurring PTSD and AUD.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 21-55 who meet the diagnostic criteria for both PTSD and AUD.
Not a fit: Patients actively seeking treatment for alcohol use disorder or those likely to experience significant alcohol withdrawal may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for individuals struggling with both PTSD and alcohol use issues.
How similar studies have performed: While the use of brexanolone has been explored in other contexts, this specific application for PTSD and AUD is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: MacKenzie R Peltier, PhD — Yale University
- Study coordinator: MacKenzie R Peltier, PhD
- Email: mackenzie.peltier@yale.edu
- Phone: 203-932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.