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RECRUITING
NCT06731335
PHASE2

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

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

Interventions

DRUG

Psilocybin

PSILOCYBIN (PEX010) 25 mg PO single dose

DRUG

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