Clinical TrialChronic PainPsilocybinPlaceboRecruiting

Psilocybin for Enhanced Analgesia in Chronic Neuropathic Pain (PEACE-PAIN)

Triple-blind, randomised, placebo-controlled Phase II feasibility trial (n=30) testing single-dose psilocybin 25 mg versus active placebo dextromethorphan 400 mg with psychological support in adults with chronic neuropathic pain.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

This pilot, randomised, triple-blind, parallel-group trial will assess feasibility, tolerability, and preliminary efficacy of a single 25 mg oral dose of psilocybin versus an active placebo (dextromethorphan 400 mg) in adults with moderate-to-severe chronic neuropathic pain.

Both arms receive structured psychological support; primary outcomes focus on feasibility metrics (recruitment, retention, adherence, missing data, adverse outcomes) and secondary outcomes assess change in pain intensity and interference through follow-up at days 1, 7, 14, 30 and 90.

Findings will inform the design of a larger multicentre RCT to evaluate psilocybin for neuropathic pain management.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single oral 25 mg psilocybin dose with psychological support (feasibility arm).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single 25 mg oral dose + psychological support

Active placebo (dextromethorphan 400 mg)

active comparator

Single oral 400 mg dextromethorphan (active placebo) with psychological support.

Interventions

  • Placebo400 mg
    via Oral• single dose• 1 doses total

    Dextromethorphan 400 mg as active placebo + psychological support

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2024-12-01
    End: 2026-12-01
  • Compounds
    PsilocybinPlacebo
  • Topic
    Chronic Pain

Locations

St. Michael's Hospital. Unity Health Toronto — Toronto, Ontario, Canada
St. Michael's Hospital. Unity Health Toronto — Toronto, Ontario, Canada

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