RecruitingPhase 2NCT06731335

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN


Sponsor

Unity Health Toronto

Enrollment

30 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Active Placebo and a drug called Psilocybin for people with chronic neuropathic pain and pain management. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

PSILOCYBIN (PEX010) 25 mg PO single dose

DRUGActive 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

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NCT06731335


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