Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
Trial Parameters
Brief Summary
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 21-65 who meet criteria for current DSM-5 diagnosis of AUD and PTSD as determined by the Alcohol System Checklist and CAPS-5. 2. Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer. 3. Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug. 4. Are English-speaking. 5. Must be willing to use contraception throughout the duration of the study. This applies to anyone, regardless of biological sex, who can cause pregnancy or become pregnant themselves. 6. Have a friend or family member who can pick them up and stay with them overnight after the DAS and who agrees to share contact information with the research team. 7. Have a primary care provider. 8. Have access to stable internet and either smart phone or computer. 9. Are willing to disclose medication use, supplement use, and intervent