The Impact of Psilocybin on Pain in Fibromyalgia Patients (PsiloFM)

This double-blind, randomized, placebo-controlled trial (n=35) will investigate the impact of psilocybin (5-10mg) on pain perception in fibromyalgia patients.

Fibromyalgia is characterised by widespread pain and other symptoms, and current therapies often provide limited relief. The study aims to explore whether low doses of psilocybin (5mg or 10mg) can alleviate pain in this population. Participants aged 18 to 65 will undergo the Cold Pressor Test and the Pain Pressure Threshold Task to assess the analgesic effects.

The study involves five visits over five weeks, including screening, treatment administration, experimental tasks, blood samples, and questionnaires.

Primary outcomes include pain tolerance and threshold, measured at various time points after administration. Secondary measures assess mood, cognition, and psychedelic experience. Hypnotic suggestions of analgesia will also be tested.

The trial is conducted at Maastricht University and Leiden University Medical Center, with Johannes G. Ramaekers as the principal investigator. It commenced in April 2024 and is estimated to be completed in December 2025.

Topic Fibromyalgia Pain
Compound Psilocybin Placebo
Country Netherlands
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Trial Details



Trial Number

Sponsors & Collaborators

McMaster University
McMaster University is a public research university in Hamilton, Canada, known for innovative learning & research across diverse fields like health sciences & engineering.

Leiden University
Leiden University Medical Center is doing several studies into psychedelics. They do this in cooperation with other universities (e.g. Utrecht University) and companies (e.g. COMPASS).

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