Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Michael's Hospital. Unity Health Toronto
RECRUITING
Toronto
St. Michael's Hospital. Unity Health Toronto
NOT_YET_RECRUITING
Toronto
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: Intervention Arm with Psilocybin
Intervention Arm with Psilocybin 25 mg single dose PO + psychological support
Placebo_comparator: Placebo
Placebo (Active) Dextromethorphan 400 mg single dose PO + psychological support
Related Therapeutic Areas
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov