Magic mushroom compound could ease fibromyalgia pain
NCT ID NCT06368492
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether low doses of psilocybin, the active ingredient in magic mushrooms, can reduce pain in people with fibromyalgia. Thirty-five adults will receive a placebo and two different low doses on separate days. Researchers will measure pain tolerance and self-reported pain to see if psilocybin helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin
- What this could lead to
- If it works, this could point toward a new way to manage fibromyalgia pain without strong side effects.
- What could go wrong
- This is a small, early-phase trial with only 35 people. The low doses may not work, and results might not apply to everyone with fibromyalgia.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Leiden University Medical Center
RECRUITINGLeiden, South Holland, 2333, Netherlands
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Maastricht University
RECRUITINGMaastricht, Limburg, 6226AK, Netherlands
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