Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

This is a feasibility study to examine the use of use of Psilocybin (magic mushrooms) to alleviate pain in chronic neuropathic pain. While theoretical mechanisms demonstrate promise, there is no clinical evidence. This vacuum of clinical evidence has been occupied by a "psychedelic hype bubble" with media communications touting psychedelics as a 'miracle cures'. The mismatch between evidence and perception creates an urgent need for RCT to fill this significant gap. This trial aims to address this gap by conducting a pilot trial assessing the feasibility, tolerability, and preliminary efficacy of psilocybin for chronic neuropathic pain to inform a future larger, multi-centre study. The purpose is to conduct a randomized control double-blinded trial of psilocybin and active placebo (dextromethorphan). At this time, the aim of the trial is to recruit 30 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study in the future.

NCT Number	NCT06731335
Lead Sponsor	Unity Health Toronto
Conditions	Chronic Neuropathic Pain, Pain Management
Enrollment	30 participants
Start Date	2025-03-05
Primary Completion	2026-08 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-30