Psilocybin for Enhanced Analgesia in Chronic NEuropathic PAIN (PEACE-PAIN)

This triple-blind, randomised, placebo-controlled Phase II trial (n=30) will assess the feasibility, tolerability, and preliminary effectiveness of psilocybin (25mg, single oral dose) for managing chronic neuropathic pain. The control group will receive an active placebo, dextromethorphan (400mg, single oral dose), with both groups receiving psychological support.

The study is sponsored by Unity Health Toronto and will be conducted at St. Michael’s Hospital in Toronto, Canada.

Researchers aim to determine whether a larger, multi-centre trial is viable by evaluating participant recruitment, adherence, and potential adverse effects. Secondary measures include changes in pain intensity and pain interference over a one-month period. Participants will be adults aged 18–65 with moderate-to-severe neuropathic pain who have not responded to at least two recommended treatments. Follow-up assessments will take place at 1, 7, 14, 30, and 90 days post-treatment. The study is expected to run from December 2024 to December 2026.

Topic Pain
Compound Psilocybin Placebo
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 December 2024
End date 01 December 2026
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 30
Sex All
Age 18- 65
Therapy No

Trial Details

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.

Trial Number NCT06731335

Data attribution

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