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Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

RecruitingPhase 2Ages 18 Years - 65 YearsAllUnity Health Toronto
NCT06731335 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 H

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • Psilocybin
  • Active Placebo
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Where

2 sites
St. Michael's Hospital. Unity Health Toronto
Toronto, Canada
St. Michael's Hospital. Unity Health Toronto
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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