Open-label, single-arm early-phase I study (n=12) testing a single 25 mg oral dose of psilocybin for individuals with prolonged grief disorder to assess feasibility and symptom change.
This single-group, open-label feasibility study will administer a single oral 25 mg dose of psilocybin to 12 adults with diagnosed prolonged grief disorder and follow safety, tolerability, and symptom measures.
Primary aims are feasibility and preliminary efficacy: to assess whether psilocybin reduces grief-related symptoms and whether subjective mystical or insightful experiences mediate clinical change.
Safety screening includes medical history, ECG, routine labs, urine toxicology and pregnancy testing; sessions occur in an observation room with monitoring for up to 10 hours and follow-up assessments post-session.
Single-arm open-label administration of 25 mg psilocybin to all participants.
Single 25 mg oral dose administered in an observation room (up to 10 hours).