Exploring the effects of psilocybin on pain in fibromyalgia patients
The Impact of Psilocybin on Pain in Fibromyalgia Patients: a Multicentre Trial.
This study is testing whether low doses of psilocybin can help people with fibromyalgia feel less pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Maastricht University Academic / other |
| Locations | 2 sites (Maastricht, Limburg and 1 other locations) |
| Trial ID | NCT06368492 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of psilocybin, a serotonergic psychedelic, on pain perception in patients with fibromyalgia. It employs a double-blind, randomized, placebo-controlled design, administering either a placebo or low doses of psilocybin (5 mg or 10 mg) to participants. The aim is to assess whether these doses can lead to significant improvements in pain ratings and overall quality of life for individuals suffering from this chronic condition. The study will also monitor participants' responses to hypnosis scripts as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of fibromyalgia and a minimum pain score of 5 out of 10.
Not a fit: Patients who regularly use psychotropic medications or psychoactive substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for managing chronic pain in fibromyalgia patients.
How similar studies have performed: While there is emerging evidence supporting the analgesic effects of psychedelics, this specific approach in fibromyalgia patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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, 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: * 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
Where this trial is running
Maastricht, Limburg and 1 other locations
- Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Johannes G. Ramaekers, PhD — Maastricht University
- Study coordinator: Mauro Cavarra, MSc
- Email: fpn-pim_p137@maastrichtuniversity.nl
- Phone: +310683029784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.