Study identification

EU PAS number

EUPAS48284

Study ID

48285

Official title and acronym

Psilocybin in patients with fibromyalgia: EEG-measured brain biomarkers of action (Psilopain)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Title: Psilocybin in patients with fibromyalgia syndrome: EEG-measured brain biomarkers of action (‘Psilopain’). Aims: To assess brain activity under psilocybin in a cohort of people with fibromyalgia. Design: A single arm, within-subjects study in 20 participants with fibromyalgia as defined by the American Rheumatological Society diagnostic criteria. Outcome Measures: The primary outcome is Lempel-Ziv complexity (LZc) of spontaneous brain activity recorded via EEG. Secondary outcomes will aim to capture broad aspects of the pain experience and related features through Magnetic Resonance Imaging (MRI), self-report measures, behavioural paradigms and qualitative interviews. Eligibility: Over 18 years of age, a good understanding of English language, registered with a primary care practice, no urgent clinical investigations or interventions for pain indicated. Procedure: Two dosing sessions, separated by four weeks with in-session EEG-recordings. Duration: This study will run for 27 months.

Study status

Ongoing
Research institutions and networks

Institutions

Imperial College London
United Kingdom
First published:
01/02/2024
InstitutionEducational Institution

Contact details

David Nutt

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Philanthropy
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable