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Magic mushroom compound could ease fibromyalgia pain

NCT ID NCT06368492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Chronic Pain fibromyalgia

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Leiden University Medical Center

    RECRUITING

    Leiden, South Holland, 2333, Netherlands

  • Maastricht University

    RECRUITING

    Maastricht, Limburg, 6226AK, Netherlands

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