Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action (Psilopain)

The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia.

Study Overview

• Status: Active, not recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Psilocybin; Behavioral: Therapeutic support

Detailed Description

This mechanistic (Non-CTIMP) study will utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity under Psilocybin. Up to 25mg of Psilocybin will be administered under standardised conditions on two occasions, separated by four weeks with in-dosing EEG recordings.

The primary end-point will take place 8 weeks from the first dosing session after which patients will be remotely monitored monthly for 6 months.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: James B Close; Phone Number: +44 (0)20 7594 1074; Email: jclose@ic.ac.uk
• Study Contact Backup: Name: Julia Bornemann; Phone Number: +44 (0)20 7594 1074; Email: j.bornemann19@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0NN
    • Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Fibromyalgia lasting for more than 3 months, as diagnosed by an appropriate medical professional using the American College of Rheumatology diagnostic criteria.

Description

Inclusion Criteria:

• Fibromyalgia lasting for more than 3 months, as diagnosed by an appropriate medical professional using the American College of Rheumatology diagnostic criteria.
• Over 18 years of age
• United Kingdom (UK) resident registered with a primary care medical practice
• Sufficiently competent in English with capacity to provide written informed consent
• Agreement for research team to contact primary and/or secondary care team over the course of the study
• No psychedelic use in the past 6 months

Exclusion Criteria:

• Current or previously diagnosed psychotic disorder or bipolar disorder
• Immediate family member with a diagnosed psychotic disorder
• History of serious suicide attempts or presence of significant suicide/self-harm risk at screening
• Emotionally unstable personality, history of mania, or other psychiatric problem that the screening clinician feels may jeopardise the therapeutic alliance and/or safe exposure to psilocybin
• Currently using medication which could interact with psilocybin including anti-psychotics, mood stabilizers & serotonergic antidepressants including selective serotonin reuptake inhibitors (SSRIs), SNRIs, and tricyclic antidepressants (TCAs)*
• On waiting list for interventional treatment for pain (e.g. surgery or targeted injections)
• Actively enrolled on pain management programme over course of study or awaiting further investigations for pain
• Contraindications to EEG components of the study (e.g., epilepsy, migraine, focal scalp sensitivity)
• MRI contraindications (e.g. claustrophobia, metal implants)
• Physical co-morbidities that are unsuitable for the psychedelic component of the study (e.g., epilepsy, severe cardiovascular disease, insulin-dependent diabetes, hepatic or renal failure e.g., CrCl < 30ml/min etc)
• Blood or needle phobia
• Positive pregnancy test at screening or during the study
• People who are breastfeeding
• Unable to engage with physical demands of dosing session (i.e. attend centre and remain in research facility for an extended period of time)
• Unable to access virtual meetings/phone for remote follow-ups
• Patients consuming more than 35 units of alcohol per week.
• Presence of new or un-investigated 'red flag' symptom indicating need for urgent investigation (e.g. upper motor neuron syndrome, gait ataxia, bladder or bowel dysfunction).
• Limited life expectancy (<18 months) or rapidly deteriorating condition that may inhibit completion of the study (6 month remote follow up).
• Currently prescribed any of the following drugs: Antiepileptics, 5HT3-receptor antagonists, Aspirin, Coumarins, Cyproheptadine, Dabigatran, Dapoxetine, Duloxetine, Lithium, Methylphenidate, Methylthioninium, Metoclopramide, NSAIDs (should be avoided), Naratriptan, Pimozide, Rasagiline, Ritonavir, St John's Wort and Vortioxetine. Tramadol and Fentanyl will be avoided due to their serotonergic action, but all other opioids will not be grounds for exclusion.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromyalgia Cohort; *As diagnosed by an appropriate medical professional according to the American College of Rheumatology(ACR) diagnostic criteria	Drug: Psilocybin; Up to 25mg of Psilocybin on 2 occasions.; Other Names: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine; Behavioral: Therapeutic support; Psychological and physical therapeutic support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lempel-Ziv complexity (LZc)	Lempel-Ziv complexity (LZc) of spontaneous brain activity recorded via EEG.	8 weeks
The Brief Experiential Avoidance Questionnaire (BEAQ)	Experiential avoidance as a part component of psychological flexibility	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI	Structural and functional magnetic resonance imaging	8 weeks
Patient reported outcome measures	Secondary outcomes will aim to capture broad aspects of the pain experience	6 months
Physiology: Heart rate, body temperature, accelerometry	Wearable technology will capture physiological outcomes	8 weeks
Qualitative interviews	Semi-structured and unstructured interviews	6 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: David Nutt, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): January 10, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Fibromyalgia; Psilocybin; Psychological Flexibility; Lempel-Ziv Complexity
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Serotonin Antagonists; Hallucinogens; Psilocybin; N,N-Dimethyltryptamine
• Other Study ID Numbers: 275349; EUPAS48284 (Other Identifier: EU PAS Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No