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Psychedelic Therapy

Psilocybin for Neuropathic Pain (PEACE-PAIN Trial)

Phase 2
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-65 years
Diagnosis of chronic neuropathic pain by a pain specialist
Must not have
Enzyme CYP2D6 deficiency as shown on pharmacogenetic test
Medications that interact with study drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month

Summary

This trial aims to investigate whether Psilocybin (magic mushrooms) can help alleviate chronic neuropathic pain. There is currently a lack of clinical evidence in this area, and the media has created

Who is the study for?
This trial is for individuals suffering from chronic neuropathic pain, including conditions like Ilioinguinal Neuralgia. Participants will be recruited from St. Michael's Hospital to determine if a larger study is feasible.
What is being tested?
The study tests the effectiveness of Psilocybin (found in magic mushrooms) against an active placebo (dextromethorphan) in managing chronic neuropathic pain through a randomized control double-blinded trial.
What are the potential side effects?
Potential side effects are not detailed here, but psilocybin can typically cause changes in perception, mood swings, nausea, and dizziness while dextromethorphan may cause mild gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with chronic nerve pain by a specialist.
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I have moderate to severe nerve pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My genetic test shows I have a CYP2D6 enzyme deficiency.
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I am not taking any medications that would interfere with the study drugs.
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I do not have a history of severe mental health issues or substance abuse in the last year.
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My heart, liver, or kidney conditions are stable and under control.
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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility to recruit 30 participants into a trial of psilocybin and active placebo to prepare for a larger multicentre trial
Secondary study objectives
Change in pain intensity from baseline to one month after interventions
Change in pain interference from baseline to one month after interventions

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention Arm with PsilocybinExperimental Treatment1 Intervention
Intervention Arm with Psilocybin 25 mg single dose PO + psychological support
Group II: PlaceboPlacebo Group1 Intervention
Placebo (Active) Dextromethorphan 400 mg single dose PO + psychological support
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
562 Previous Clinical Trials
453,921 Total Patients Enrolled
1 Trials studying Neuropathic Pain
30 Patients Enrolled for Neuropathic Pain
~20 spots leftby Aug 2026
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