Chronic pain is one of the leading causes of disability worldwide. Fibromyalgia, a condition characterised by widespread chronic pain, remains poorly understood with limited options for treatment. Psilocybin may provide an opportunity to affect the personal impact of pain in people living with fibromyalgia, and here, we wish to better understand how it may work.

For this study, we are recruiting adults with fibromyalgia who meet our study criteria (see below). Those who are deemed eligible at screening will attend eight study visits over eight weeks. Participants will receive psilocybin at least once, with a dose up to 25mg. Across these eight visits, there will be three magnetic resonance imaging (MRI) scans, six electrophoretogram (EEG) recordings, and a range of questionnaires and interviews. There will also be a remote follow-up period of six months following the final study visit.

Key Inclusion Criteria

• Fibromyalgia as diagnosed by an appropriate medical professional, lasting for more than three months.
• 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 six months

Key Exclusion Criteria

• Current or previously diagnosed psychotic disorder, bipolar disorder, or mania
• Immediate family member with a diagnosed psychotic disorder
• History of serious suicide attempts
• 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
• Medical contraindications e.g., epilepsy, migraine, focal scalp sensitivity
• MRI contraindications (e.g. metal implants)
• Blood or needle phobia
• People who are pregnant, planning to get pregnant, or currently 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
  Limited life expectancy (<18 months)
• Patients consuming more than 35 units of alcohol per week

*Antipsychotic medications and mood stabilisers may attenuate the effects of psilocybin. In this population, people may be using these medications as adjunctive treatments for coexisting depression, anxiety, and also for sleep. Antipsychotic medications are contraindicated and thus those on antipsychotic medication (e.g., olanzapine) will not be eligible to take part in this study. The same is true for mood stabilizing mediations and many antidepressant medications with serotonergic action, including SSRIs, SNRIs, and TCAs. Therefore, we will not be recruiting patients currently prescribed any antidepressant medication, with the exception of Bupoprion, which is not serotonergically active.

Please note that Psilocybin is not a licenced drug or treatment for fibromyalgia and therefore cannot be prescribed outside specific timepoints during this study regardless of any positive outcomes. For more information and to register your interest visit apply for a remote video screening.

Please only contact this email address with queries related to the PsiloPain study. For all other enquiries please email psychedelicresearch@imperial.ac.uk.