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.
Trial Details
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.NCT Number NCT06368492
Sponsors & Collaborators
McMaster UniversityMcMaster 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).