Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

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.

Timeline

Start

2025-03-05

Primary completion

2026-08

Completion

2026-12

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications