Actively Recruiting
Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
Led by Unity Health Toronto · Updated on 2025-03-30
30
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-65 years of age
- Diagnosis of chronic neuropathic pain by a pain specialist
- Moderate-to-severe neuropathic pain measured by PROMIS
- Tried at least two recommended neuropathic pain medications without meaningful symptom improvement
- Sufficient English skills to participate in psychotherapy
- Use of highly effective or double-barrier contraception if of childbearing potential
You will not qualify if you...
- History of dextromethorphan addiction or abuse
- Enzyme CYP2D6 deficiency shown by pharmacogenetic test
- Lifetime or family history of primary psychotic disorder, bipolar disorder, borderline personality disorder, paranoid personality disorder, current suicidal ideation, or substance use disorder within past 12 months
- Use of medications that interact with study drugs
- Unstable or uncontrolled medical conditions including cardiovascular, liver, or end-stage renal disease
- Previous lifetime use of serotonergic psychedelic drugs
- Nursing or pregnant women
- Any other significant medical illness that may interfere with study results or pose health risks
AI-Screening
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Trial Site Locations
Total: 2 locations
1
St. Michael's Hospital. Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
2
St. Michael's Hospital. Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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