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METHODS article

Front. Psychiatry
Sec. Psychopharmacology
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1320780
This article is part of the Research Topic Down the rabbit hole – the psychological and neural mechanisms of psychedelic compounds and their use in treating mental health and medical conditions View all 14 articles

Study Protocol for "Psilocybin in patients with fibromyalgia: Brain biomarkers of action"

Provisionally accepted
Julia Bornemann Julia Bornemann 1*James B. Close James B. Close 1Kirran Ahmad Kirran Ahmad 1Tommaso Barba Tommaso Barba 1Kate Godfrey Kate Godfrey 1Lauren Macdonald Lauren Macdonald 1David Erritzoe David Erritzoe 1David Nutt David Nutt 1Robin Carhart-Harris Robin Carhart-Harris 1,2
  • 1 Imperial College London, London, United Kingdom
  • 2 University of California, San Francisco, San Francisco, California, United States

The final, formatted version of the article will be published soon.

    Background: Chronic pain is a leading cause of disability worldwide. Fibromyalgia is a particularly debilitating form of widespread chronic pain. Fibromyalgia remains poorly understood, and treatment options are limited or moderately effective at best. Here, we present a protocol for a mechanistic study investigating the effects of psychedelic-assisted-therapy in a fibromyalgia population. The principal focus of this trial is the central mechanism(s) of psilocybin-therapy i.e., in the brain and on associated mental schemata, primarily captured by electroencephalography (EEG) recordings of the acute psychedelic state, plus pre and post magnetoencephalography (MRI).Methods: Twenty participants with fibromyalgia will complete 8 study visits over 8 weeks. This will include two dosing sessions where participants will receive psilocybin at least once, with doses varying up to 25mg. Our primary outcomes are 1) Lempel-Ziv complexity (LZc) recorded acutely using EEG, and the 2) (Brief Experiential Avoidance Questionnaire (BEAQ) measured at baseline and primary endpoint. Secondary outcomes will aim to capture broad aspects of the pain experience and related features through neuroimaging, self-report measures, behavioural paradigms, and qualitative interviews. Pain Symptomatology will be measured using the Brief Pain Inventory Interference Subscale (BPI-IS). Further neurobiological investigations will include functional MRI (fMRI) and diffusion tensor imaging (changes from baseline to primary endpoint), and acute changes in pre-vs post-acute spontaneous brain activity -plus event-related potential functional plasticity markers, captured via EEG.The results of this study will provide valuable insight into the brain mechanisms involved in the action of psilocybin-therapy for fibromyalgia with potential implications for the therapeutic action of psychedelic-therapy more broadly. It will also deliver essential data to inform the design of a potential subsequent RCT.

    Keywords: psilocybin, Psychedelic therapy, Chronic Pain, Fibromyaglia, EEG

    Received: 12 Oct 2023; Accepted: 04 Mar 2024.

    Copyright: © 2024 Bornemann, Close, Ahmad, Barba, Godfrey, Macdonald, Erritzoe, Nutt and Carhart-Harris. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Julia Bornemann, Imperial College London, London, United Kingdom

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