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Het effect van psilocybine op pijn bij fibromyalgiepatiënten: een multicenter trial
EU CTIS ID: 2024-516890-63-00
What this study is testing
Primary Objective: The primary objective is to assess the effects of low psilocybin doses on pain perception in FM patients and their association with BDNF levels.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 65 years
- 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
- Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2
- Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)
- A minimum NRS pain score of 5 out of 10
You likely can't join if
- Presence of inflammatory rheumatic diseases such as ankylosing spondylitis.
- History of cardiac dysfunctions (arrhythmia, ischemic heart disease…)
- For women: no use of a reliable contraceptive
- Presence or history of psychotic, bipolar or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination
- Current mental health diagnosis
- Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
See the full eligibility criteria
- Age between 18 and 65 years
- 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
- Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2
- Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)
- 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 regular use of psychotropic medication such as opiates, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines, MAO-A inhibitors. 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.
- Presence of inflammatory rheumatic diseases such as ankylosing spondylitis.
- History of cardiac dysfunctions (arrhythmia, ischemic heart disease…)
- For women: no use of a reliable contraceptive
- Presence or history of psychotic, bipolar or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination
- Current mental health diagnosis
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.