The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia.
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
20
Up to 25mg of Psilocybin on 2 occasions.
Psychological and physical therapeutic support
Imperial College London
London, United Kingdom
Lempel-Ziv complexity (LZc)
Lempel-Ziv complexity (LZc) of spontaneous brain activity recorded via EEG.
Time frame: 8 weeks
The Brief Experiential Avoidance Questionnaire (BEAQ)
Experiential avoidance as a part component of psychological flexibility
Time frame: 8 weeks
MRI
Structural and functional magnetic resonance imaging
Time frame: 8 weeks
Patient reported outcome measures
Secondary outcomes will aim to capture broad aspects of the pain experience
Time frame: 6 months
Physiology: Heart rate, body temperature, accelerometry
Wearable technology will capture physiological outcomes
Time frame: 8 weeks
Qualitative interviews
Semi-structured and unstructured interviews
Time frame: 6 months
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