Using psilocybin to help manage chronic neuropathic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial examines the feasibility of using psilocybin, a psychedelic compound, to alleviate chronic neuropathic pain in adults. It is a randomized, double-blind, placebo-controlled study involving 30 participants who have not found relief from previous pain medications. Participants will receive either psilocybin or an active placebo (dextromethorphan) along with psychological support, with outcomes measured for feasibility and changes in pain intensity. The goal is to gather preliminary data to inform a larger future study.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Michael's Hospital. Unity Health Toronto
  Toronto, Ontario, Canada Recruiting
• St. Michael's Hospital. Unity Health Toronto
  Toronto, Ontario, Canada Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.