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).

The study, led by Nathan Brashares Sackett at the University of Washington, aims to explore whether psilocybin-assisted therapy can provide a safe and effective treatment for individuals struggling with both PTSD and AUD—two conditions that often occur together but have not yet been studied in combination with psychedelic therapy. Participants, aged 18–65, will receive either psilocybin (25mg) or an inactive placebo in a clinical setting, alongside psychological support that offers reassurance, active listening, and an empathetic presence during the drug session. The study includes two preparation sessions, one drug administration session, and three integration sessions.

Participants who initially receive the placebo will be given the opportunity to receive psilocybin in an open-label (non-blinded) extension phase. The study will track safety outcomes during and after the session, assess the effectiveness of psilocybin on PTSD and AUD symptoms at 4 weeks post-treatment, and evaluate long-term durability at 12 and 24 weeks. Findings from this study could contribute to the growing body of evidence on psychedelic-assisted therapy for co-occurring mental health conditions.

Trial Details

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, efficacy, and durability of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 18-65) 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 and effective treatment for participants.

Trial Number NCT06853912

Data attribution

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