Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Neuropathic Pain, Pain Management

In brief

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 facts

Study ID

NCT06731335

Run by

Unity Health Toronto

People needed

30

Starts

2025-03-05

Expected to finish

2026-12-01

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 years of age
• Diagnosis of chronic neuropathic pain as determined by a pain specialist
• Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS)
• Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms
• Sufficient command of English to participate in psychotherapy
• For participants of childbearing potential, use of a highly effective or double-barrier methods of contraception.

You may not qualify if…

• History of Dextromethorphan addiction or abuse.
• Enzyme CYP2D6 deficient as shown on the pharmacogenetic test.
• Underlying psychiatric conditions: lifetime or family history of a primary psychotic disorder, bipolar disorder, borderline personality disorder, paranoid personality disorder, current suicidal ideation, and substance use disorder within the past 12 months as assessed by history and confirmed by the Mini International Neuropsychiatric Interview (MINI)
• Medications that interact with study drugs
• Medical condition that is unstable or inadequately controlled, including cardiovascular disease, liver disease, or end-stage renal disease
• Previous lifetime use of a serotonergic psychedelic drug
• Nursing or pregnant women.
• Any other clinically significant medical illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study

Where it is running

• St. Michael's Hospital. Unity Health Toronto — Toronto, Ontario, Canada (enrolling)
• St. Michael's Hospital. Unity Health Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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