Psilocybin with Psychological Support (Psi-PS) for Military Veterans and First Responders with Co-occurring PTSD & Alcohol Use Disorder (AUD) (Psi-PS)
This Phase II, double-blind, placebo-controlled trial (n=40) will investigate the safety, effectiveness, and lasting effects of psilocybin (25mg) combined with psychological support (Psi-PS) in military veterans and first responders with both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD).
Details
Randomized, double-blind, placebo-controlled Phase II trial (n≈40) testing a single 25 mg oral dose of psilocybin (PEX010) plus nondirective psychological support versus inert placebo with identical psychological support in veterans and first responders with co-occurring AUD and PTSD.
Intervention includes two 60-minute telehealth preparation sessions, one 6–8 hour drug administration session with two facilitators present, and three 60-minute telehealth integration sessions; placebo recipients are offered open-label psilocybin at 4 weeks.
Primary objective is to characterise safety during the drug administration session and in follow-up to 24 weeks; secondary and exploratory measures assess subjective experience and clinical outcomes at multiple post-DAS timepoints.