Fibromyalgia Fibromyalgia
Conditions
Interventions
35 FM patients will receive placebo and oral doses of 5 mg or 10 mg of
psilocybin in a double-blind, randomized, placebo-controlled design. All
participants will receive a brief hypnotic induction a
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age between 18 and 65 years • Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2 • Fulfilment of the American College of Rheumatology criteria for FM diagnosis • A minimum NRS pain score of 5 out of 10 • Proficient knowledge of the Dutch or English language • Written Informed Consent • Understanding the procedures and the risks associated with the study • No use of regular use of psychotropic medication such as opiates, antidepressants, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines. Non pharmacological regimens will be allowed along 1 rescue therapy such as acetaminophen
Exclusion criteria
Exclusion criteria: Fibromyalgia Patients: • Presence of any other painful condition such as inflammatory rheumatic diseases, migraines or headaches and of other chronic or acute medical conditions • Presence of any other psychiatric condition such as primary major depressive disorder, anxiety disorders or substance use disorder. • Have a history of psychotic or bipolar disorders • Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks) • Tobacco smoking (>20 cigarettes per day) • Excessive drinking (>20 alcoholic consumptions per week) • Psychotic disorder in first-degree relatives • Pregnancy or lactation • Hypertension (diastolic >90 mmHg; systolic >140 mmHg) • History of cardiac dysfunctions (arrhythmia, ischemic heart disease*) • For women: no use of a reliable contraceptive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes will be subjective and objective measures of pain endurance and pain threshold (i.e.,Pressure Pain Threshold Cold, Pressor Test, BPI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measures will assess the effects that placebo and psilocybin will have on mood, cognition and psychedelic experience. The employed tests will be the following: Visual Analogue Scale (VAS), Profile of Mood States (POMS), Clinical Administered Dissociative States Scale (CADSS), Brief Symptoms Inventory (BSI), Altered States of Consciousness (5D-ASC), Ego Dissolution Inventory (EDI), Blood pressure (BP), Heart rate (HR), Multifaceted Empathy Test (MET), Alternate Use Test (AUT), Digit Symbol Substitution Test (DSST), Psychomotor Vigilance Task (PVT), Brief Pain Inventory (BPI). | — |
Countries
Netherlands
Outcome results
None listed