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Chronic Neuropathic PainPhase 2PEACE-PAINNCT06731335

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

A Phase 2 study testing Psilocybin in people with Chronic Neuropathic Pain and Pain Management, run by Unity Health Toronto at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Neuropathic Pain, Pain Management
What is being tested?
Psilocybin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesCanada
Study dates
5 Mar 2025to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada2 sites, 2 recruiting

  • St. Michael's Hospital. Unity Health Toronto

    Toronto, Ontario, M5B 1W8

    Karim Ladha, MD MSc FRCPC, 416-864-5825, karim.ladha@mail.utoronto.ca

    Janneth A Pazmino-Canizares, MSc, 4168646060 ext. 49561, Janneth.Pazmino-Canizares@unityhealth.to

    Not yet recruiting

  • St. Michael's Hospital. Unity Health Toronto

    Toronto, Ontario, M5B 1W8

    Janneth A Pazmino-Canizares, MSc, 4168646060, Janneth.Pazmino-Canizares@unityhealth.to

    Recruiting

Other trials in Canada

About this study

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.

Read more

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.

Read the 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

Being tested
Psilocybin, Active Placebo
Keywords
chronic pain, neuropathic pain, psychodelics, psilocybin, chronic neuropathic pain
Medical subject headings
Agnosia, Chronic Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    Also called Psychotherapy

    PSILOCYBIN (PEX010) 25 mg PO single dose

  • Active PlaceboDrug

    Also called Psychotherapy

    Dextromethorphan 400 mg PO single dose

Study groups in NCT06731335
Study groupRoleWhat they receive
Intervention Arm with PsilocybinExperimentalIntervention Arm with Psilocybin 25 mg single dose PO + psychological support
Receives: Drug: Psilocybin
PlaceboPlacebo comparatorPlacebo (Active) Dextromethorphan 400 mg single dose PO + psychological support
Receives: Drug: Active Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility to recruit 30 participants into a trial of psilocybin and active placebo to prepare for a larger multicentre trial

    Recruitment rate and withdrawal rate (Acceptability and feasibility study)

    Measured: 18 months

Secondary outcomes (2)

  1. Change in pain intensity from baseline to one month after interventions

    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)

    Measured: one month

  2. Change in pain interference from baseline to one month after interventions

    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)

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start5 Mar 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731335
Sponsor's protocol ID
P-005
Acronym
PEACE-PAIN
Status last verified
Mar 2025
First submitted
28 Nov 2024
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • Griffiths RR, Johnson MW, Richards WA, Richards BD, McCann U, Jesse R. Psilocybin occasioned mystical-type experiences: immediate and persisting dose-related effects. Psychopharmacology (Berl). 2011 Dec;218(4):649-65. doi: 10.1007/s00213-011-2358-5. Epub 2011 Jun 15.

    PubMed 21674151

  • Carbonaro TM, Bradstreet MP, Barrett FS, MacLean KA, Jesse R, Johnson MW, Griffiths RR. Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. J Psychopharmacol. 2016 Dec;30(12):1268-1278. doi: 10.1177/0269881116662634. Epub 2016 Aug 30.

    PubMed 27578767

  • Yaden DB, Potash JB, Griffiths RR. Preparing for the Bursting of the Psychedelic Hype Bubble. JAMA Psychiatry. 2022 Oct 1;79(10):943-944. doi: 10.1001/jamapsychiatry.2022.2546.

    PubMed 36044208

  • Glynos NG, Pierce J, Davis AK, McAfee J, Boehnke KF. Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia. J Psychoactive Drugs. 2023 Jan-Mar;55(1):73-84. doi: 10.1080/02791072.2021.2022817. Epub 2022 Jan 10.

    PubMed 35001856

  • Ramachandran V, Chunharas C, Marcus Z, Furnish T, Lin A. Relief from intractable phantom pain by combining psilocybin and mirror visual-feedback (MVF). Neurocase. 2018 Apr;24(2):105-110. doi: 10.1080/13554794.2018.1468469. Epub 2018 May 15.

    PubMed 29764303

  • Bornemann J, Close JB, Spriggs MJ, Carhart-Harris R, Roseman L. Self-Medication for Chronic Pain Using Classic Psychedelics: A Qualitative Investigation to Inform Future Research. Front Psychiatry. 2021 Nov 12;12:735427. doi: 10.3389/fpsyt.2021.735427. eCollection 2021.

    PubMed 34867525

  • Bondesson E, Larrosa Pardo F, Stigmar K, Ringqvist A, Petersson IF, Joud A, Schelin MEC. Comorbidity between pain and mental illness - Evidence of a bidirectional relationship. Eur J Pain. 2018 Aug;22(7):1304-1311. doi: 10.1002/ejp.1218. Epub 2018 Apr 16.

    PubMed 29577509

  • Kuner R, Flor H. Structural plasticity and reorganisation in chronic pain. Nat Rev Neurosci. 2017 Jan 20;18(2):113. doi: 10.1038/nrn.2017.5. No abstract available.

    PubMed 28704354

  • Carhart-Harris RL, Leech R, Hellyer PJ, Shanahan M, Feilding A, Tagliazucchi E, Chialvo DR, Nutt D. The entropic brain: a theory of conscious states informed by neuroimaging research with psychedelic drugs. Front Hum Neurosci. 2014 Feb 3;8:20. doi: 10.3389/fnhum.2014.00020. eCollection 2014.

    PubMed 24550805

  • Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020 Jul;45(7):486-494. doi: 10.1136/rapm-2020-101273. Epub 2020 May 4.

    PubMed 32371500

  • MacCallum CA, Lo LA, Pistawka CA, Deol JK. Therapeutic use of psilocybin: Practical considerations for dosing and administration. Front Psychiatry. 2022 Dec 1;13:1040217. doi: 10.3389/fpsyt.2022.1040217. eCollection 2022.

    PubMed 36532184

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Chronic Neuropathic Pain and Pain Management, run by Unity Health Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731335, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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