Study of Psilocybin to Reduce Moderate-to-Severe Chronic Neuropathic Pain Randomized, Double-Blind Trial With Active Placebo in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating psilocybin magic mushrooms as a possible treatment to reduce pain in adults with moderate-to-severe chronic neuropathic pain. This phase II study aims to address the lack of clinical evidence by conducting a randomized, double-blinded trial comparing psilocybin to an active placebo. The trial focuses on assessing feasibility, tolerability, and early signs of pain relief to inform a larger future study. Participants will be randomly assigned to receive either a single oral dose of 25 mg psilocybin or a single oral dose of 400 mg dextromethorphan as an active placebo. Both groups will receive psychological support during the study. Follow-up visits are scheduled at 1, 7, 14, 30, and 90 days after dosing to monitor progress and collect data. During the study, participants will undergo assessments of pain intensity and interference, along with monitoring of recruitment success, consent rates, adherence, and any adverse effects. The study team will use questionnaires and patient-reported outcomes to evaluate changes from baseline. The total participation includes these follow-ups over approximately three months, with the main outcome being the feasibility of conducting a larger multicenter trial.

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN