About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Psilocybin
- Active Placebo