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

Sponsor

Imperial College London (Other)

Overall Status

Recruiting

CT.gov ID

NCT05548075

Collaborator

(none)

Enrollment

Location

24.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Jan 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Fibromyalgia Cohort *As diagnosed by an appropriate medical professional according to the 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

Arm

Intervention/Treatment

Fibromyalgia Cohort

*As diagnosed by an appropriate medical professional according to the 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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 SSRIs, SNRIs, and 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.