THE IMPACT OF PSILOCYBIN ON PAIN IN FIBROMYALGIA PATIENTS: A MULTICENTER TRIA

Phase 2

Conditions: Fibromyalgia

Registration Number: NL-OMON55974

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 35

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 <=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 and monitored.
• 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes will be subjective and objective measures of pain endurance<br /><br>and pain threshold (i.e.,Pressure Pain Threshold Cold, Pressor Test, BPI).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary measures will assess the effects that placebo and psilocybin will<br /><br>have on mood, cognition and psychedelic experience. The employed tests will be<br /><br>the following:<br /><br>Visual Analogue Scale (VAS), Profile of Mood States (POMS), Clinical<br /><br>Administered Dissociative States Scale (CADSS), Brief Symptoms Inventory (BSI),<br /><br>Altered States of Consciousness (5D-ASC), Ego Dissolution Inventory (EDI),<br /><br>Blood pressure (BP), Heart rate (HR), Multifaceted Empathy Test (MET),<br /><br>Alternate Use Test (AUT), Digit Symbol Substitution Test (DSST), Psychomotor<br /><br>Vigilance Task (PVT), Brief Pain Inventory (BPI). </p><br>