Psilocybin for Enhanced Analgesia in Chronic NEuropathic PAIN (PEACE-PAIN)

March 25, 2025 updated by: Unity Health Toronto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Brief title PEACE-PAIN Trial Indication Adult patients suffering from chronic neuropathic pain Condition(s) of focus of study Moderate-to-severe chronic neuropathic pain Number of participants 30 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome Change in pain intensity and pain interference Study design Study type: An intervention trial Allocation: Randomized Intervention model: 2-Arm Parallel Group Primary purpose: Feasibility Phase: Phase II Masking Participants, all study team including outcome assessors

Test Products, Dose, and Mode of Administration Treatment arm: Psilocybin 25mg + placebo PO single dose plus psychological support Placebo arm: Dextromethorphan 400mg PO single dose plus psychological support

Follow-Up Days: 1, 7, 14, 30, and 90

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
      • Toronto, Ontario, Canada, M5B 1W8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm with Psilocybin
Intervention Arm with Psilocybin 25 mg single dose PO + psychological support
Drug: Psilocybin
PSILOCYBIN (PEX010) 25 mg PO single dose
Other Names:
  • Psychotherapy
Placebo Comparator: Placebo
Placebo (Active) Dextromethorphan 400 mg single dose PO + psychological support
Drug: Active Placebo
Dextromethorphan 400 mg PO single dose
Other Names:
  • Psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility to recruit 30 participants into a trial of psilocybin and active placebo to prepare for a larger multicentre trial
Time Frame: 18 months
Recruitment rate and withdrawal rate (Acceptability and feasibility study)
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity from baseline to one month after interventions
Time Frame: one month
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS Pain Intensity, Pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)
one month
Change in pain interference from baseline to one month after interventions
Time Frame: one month
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference, Pain interference scale- 6 items, 5 Likert scale (the higher the score the higher the interference from pain)
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data has been planned to be shared with other researchers at this point, since this is a feasibility study with only 30 participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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