Recruiting
Phase 2

Psilocybin

Sponsor:

Unity Health Toronto

Code:

NCT06731335

Conditions

Chronic Neuropathic Pain

Pain Management

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Active Placebo

Study Details

Brief 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.

Conditions

Chronic Neuropathic Pain

Pain Management

Study ID

NCT06731335

Start date

Mar 5, 2025

Status verified date

Mar, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Psilocybin

PSILOCYBIN (PEX010) 25 mg PO single dose

Active Placebo

Dextromethorphan 400 mg PO single dose

Primary outcome measure

  • Feasibility to recruit 30 participants into a trial of psilocybin and active placebo to prepare for a larger multicentre trial [ Time Frame: 18 months ]

Central Contacts and Locations

Locations

St. Michael's Hospital. Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Janneth A Pazmino-Canizares, MSc

4168646060Janneth.Pazmino-Canizares@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • chronic pain
  • neuropathic pain
  • psychodelics
  • psilocybin
  • chronic neuropathic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-03-30.