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

NCT05548075 | Unknown

• 2 other identifiers: 275349EUPAS48284
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Psilocybin; Lempel-Ziv Complexity; Psychological Flexibility; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• MRI

  8 weeks

• Patient reported outcome measures

  6 months

• Physiology: Heart rate, body temperature, accelerometry

  8 weeks

• Qualitative interviews

  6 months

Study Arms (1)

Fibromyalgia Cohort

\*As diagnosed by an appropriate medical professional according to the American College of Rheumatology(ACR) diagnostic criteria

Drug: Psilocybin; Behavioral: Therapeutic support

Interventions

Psilocybin DRUG

Up to 25mg of Psilocybin on 2 occasions.

Also known as: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine

Fibromyalgia Cohort

Therapeutic support BEHAVIORAL

Psychological and physical therapeutic support

Fibromyalgia Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Psilocybin; Self-Help Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Organizations; Health Care Economics and Organizations

Study Officials

• David Nutt

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: August 15, 2022
• Primary Completion: January 10, 2024
• Study Completion: July 30, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

GB (1)