Triple-blind, randomised, placebo-controlled Phase II feasibility trial (n=30) testing single-dose psilocybin 25 mg versus active placebo dextromethorphan 400 mg with psychological support in adults with chronic neuropathic pain.
This pilot, randomised, triple-blind, parallel-group trial will assess feasibility, tolerability, and preliminary efficacy of a single 25 mg oral dose of psilocybin versus an active placebo (dextromethorphan 400 mg) in adults with moderate-to-severe chronic neuropathic pain.
Both arms receive structured psychological support; primary outcomes focus on feasibility metrics (recruitment, retention, adherence, missing data, adverse outcomes) and secondary outcomes assess change in pain intensity and interference through follow-up at days 1, 7, 14, 30 and 90.
Findings will inform the design of a larger multicentre RCT to evaluate psilocybin for neuropathic pain management.
Single oral 25 mg psilocybin dose with psychological support (feasibility arm).
Single 25 mg oral dose + psychological support
Single oral 400 mg dextromethorphan (active placebo) with psychological support.
Dextromethorphan 400 mg as active placebo + psychological support