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

Fibromyalgia Clinical Trial

— Psilopain  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05548075
• Other study ID #: 275349
• Secondary ID: EUPAS48284
• Status: Active, not recruiting
• Start date: August 15, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 30, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Psilocybin
Up to 25mg of Psilocybin on 2 occasions.

Behavioral:
• Therapeutic support
Psychological and physical therapeutic support

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lempel-Ziv complexity (LZc)	Lempel-Ziv complexity (LZc) of spontaneous brain activity recorded via EEG.	8 weeks
Primary	The Brief Experiential Avoidance Questionnaire (BEAQ)	Experiential avoidance as a part component of psychological flexibility	8 weeks
Secondary	MRI	Structural and functional magnetic resonance imaging	8 weeks
Secondary	Patient reported outcome measures	Secondary outcomes will aim to capture broad aspects of the pain experience	6 months
Secondary	Physiology: Heart rate, body temperature, accelerometry	Wearable technology will capture physiological outcomes	8 weeks
Secondary	Qualitative interviews	Semi-structured and unstructured interviews	6 months