Fibromyalgia
Conditions
Interventions
Product Name: Psilocybin
Pharmaceutical Form: Capsule
INN or Proposed INN: Psilocybine
CAS Number: 520-52-5
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
Pha
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fibromyalgia Patients: • 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 [37] • A minimum NRS pain score of 5 out of 10 • Proficient knowledge of the English language • Written Informed Consent • Understanding the procedures and the risks associated with the study • Free from or discontinuation of psychotropic medication such as opiates, antidepressants, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines since at least 5 days before the beginning of the study. Non pharmacological regimens will be allowed along 1 rescue therapy such as acetaminophen =4,000 mg/day, ibuprofen =1,200 mg/day, naproxen =660 mg/day, or ketoprofen =75 mg/day. Use of paracetamol (PCM) and non-steroidal anti-inflammatory drugs (NSAIDS) will be allowed. • Willingness to refrain from taking psychoactive substances during the study. • Willingness to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study days • Willingness not to drive a traffic vehicle or to operate machines within 24 h after substance administration Healthy volunteers: • Age between 18 and 65 years • Proficient knowledge of the English language • Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2 • Written Informed Consent • Understanding the procedures and the risks associated with the study • Absence of any major medical condition as determined by medical examination and laboratory analysis • Absence of any major psychological condition as determined by medical examination • Free from psychotropic medication • Willingness to refrain from taking psychoactive substances during the study. • Willingness to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day. • Willingness not to drive a traffic vehicle or to operate machines within 24 h after substance administration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 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) • 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 Healthy volunteers: • History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination) • Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks) • Pregnancy or lactation • Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg) • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) • Psychotic disorder in first-degree relatives • Any chronic or acute medical condition • History of cardiac dysfunctions (e.g., arrhythmia, ischemic heart disease) • For women: no use of a reliable contraceptive • Tobacco smoking (>20 per day) • Excessive drinking (>20 alcoholic consumptions per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effects of low psilocybin doses on pain endurance and painfulness ratings in Fibromyalgia patients.;Secondary Objective: The secondary objective is to assess the impact of low psilocybin doses on mood, cognition, personality and psychedelic experience in Fibromyalgia patients and healthy volunteers.;Primary end point(s): Pain tolerance (in seconds) Pressure Pain Threshold Subjective painfulness ratings;Timepoint(s) of evaluation of this end point: Pain will be assessed 1 hour and a half and 4 hours after each psilocybin administration via Visual Analogue Scales, Pressure Pain Threshold and Cold Pressor Test. At the end of each experimental session, and 1 week after the last study day, the Brief Pain Inventory will be administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measures of mood, cognition, personality and psychedelic experience in Fibromyalgia patients and healthy volunteers.;Timepoint(s) of evaluation of this end point: Mood, cognition, personality and psychedelic experience in Fibromyalgia patients and healthy volunteers will be measured repeatedly at multiple timepoints during each experimental session. Measures of Fibromyalgia impact and absorption will be administered 1 week after the last study day. | — |
Countries
Netherlands
Contacts
Public ContactStudy Coordinator
Maastricht University
Outcome results
None listed