About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years
Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)
A minimum Numeric Rating Scale (numeric rating scale) pain score of 5 out of 10
Disqualifiers
Presence of any other painful condition such as inflammatory rheumatic diseases, migraines or headaches and of other chronic or acute medical conditions
Presence or history of any other psychiatric condition such as primary major depressive disorder, anxiety disorders or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination
Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
Tobacco smoking (>20 per day)
Trial design
Single group
Treatments tested in this trial
Psilocybin
DrugEach participant will receive 2 different doses of psilocybin (5mg and 10mg) and a matching placebo on three separate occasions.
Hypnosis script
BehavioralAll participants will receive a brief hypnotic induction aimed at producing analgesia before the second administration of CPT
Treatment groups
Trial outcomes
Primary outcomes
Ischemic Pain perception
Pain tolerance (seconds) in the Cold Pressor Task
Pressure-evoked Pain perception
Pain threshold (kPa) in the Pressure Pain Threshold
Self-reported pain
Painfulness Visual Analogue Scale (0: no pain; 10 worst pain)
Secondary outcomes
Subjective effects: psychedelic phenomenology
5 Dimensions of altered states of consciousness (5D-ASC)
Subjective effects: mood
Profile of mood states (POMS)
Subjective effects: intensity of effects
Intensity of effects Visual Analogue Scale (VAS) (0: not under the influence; 10: very much under the influence)
Subjective effects: Ego dissolution
Ego Dissolution Inventory(EDI)
Sponsors and contacts
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Maastricht University
Lead sponsor
Leiden University Medical Center
Collaborator