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Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
Sponsor: Unity Health Toronto
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-03-05
Completion Date
2026-12
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Psilocybin
PSILOCYBIN (PEX010) 25 mg PO single dose
Active Placebo
Dextromethorphan 400 mg PO single dose
Locations (2)
St. Michael's Hospital. Unity Health Toronto
Toronto, Ontario, Canada
St. Michael's Hospital. Unity Health Toronto
Toronto, Ontario, Canada