Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
Open-label pilot, single-arm Phase II study (n=10) evaluating safety and feasibility of an 8-week psilocybin-assisted psychotherapy intervention (25 mg plus optional 37.5 mg) to support opioid tapering in adults with chronic pain.
Details
Open-label, non-randomized pilot enrolling 10 adults with noncancer chronic pain on long-term opioid therapy to assess safety, tolerability, and feasibility of psilocybin-assisted psychotherapy to support opioid tapering.
Intervention comprises an 8-week ACT-based preparatory, dosing and integration programme with one mandatory 25 mg oral dose of standardized natural psilocybin (PEX010) and an optional 37.5 mg dose one month later; opioid tapering is physician-supervised beginning after the first integration session.
Outcomes include adverse events, retention, opioid reduction and maintenance, patient-reported benefits/harms, psychedelic experience measures, cravings/withdrawal, pain symptoms, and mechanistic psychological measures with follow-up to 6 months.