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
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