Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
Phase III, randomized, quadruple-blind, placebo-controlled parallel-arm RCT (n=120) testing psilocybin microdosing (2–3 mg, 4 days/week for 2 weeks) versus placebo to reduce psychological and existential distress in patients receiving palliative care.
Details
Multi-site, randomized, double-blind, placebo-controlled parallel trial enrolling 120 patients with advanced illness and psychological distress to compare psilocybin microdosing with matched placebo; primary aim is reduction in psychological distress.
Intervention: oral psilocybin 2 mg if <55 kg or 3 mg if ≥55 kg taken Monday, Tuesday, Thursday and Friday for two consecutive weeks (8 dosing days). All participants are offered open-label microdosing after the 2-week follow-up, with an optional year-long extension.