Using psilocybin to help manage chronic neuropathic pain
Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
This study is testing if psilocybin can help adults with chronic nerve pain find relief when other medications haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT06731335 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of moderate-to-severe chronic neuropathic pain who have not experienced meaningful improvement from previous medications.
Not a fit: Patients with a history of substance use disorders, certain psychiatric conditions, or those who are CYP2D6 deficient may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to managing chronic neuropathic pain for patients who have not responded to conventional treatments.
How similar studies have performed: While there is a growing interest in the use of psychedelics for pain management, this specific approach is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario and 1 other locations
- St. Michael's Hospital. Unity Health Toronto — Toronto, Ontario, Canada (Not_yet_recruiting)
- St. Michael's Hospital. Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.