RecruitingNot applicable

The Impact of Psilocybin on Pain in Fibromyalgia Patients

NCT06368492 · PsiloFM · Maastricht University

Recruiting

Status

Accepting participants

Not applicable

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Ischemic Pain perception
Measured over 1.5, 2.5 and 4 hours after administration
Pressure-evoked Pain perception
Measured over 1.5 and 4 hours after administration
Self-reported pain
Measured over 1.5, 2.5 and 4 hours after administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

2 study sites

Facility	City	Region	Country
Maastricht University	Maastricht	Limburg	Netherlands
Leiden University Medical Center	Leiden	South Holland	Netherlands

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06368492 on ClinicalTrials.gov →

Last updated in the registry 2025-09-15. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Indication

Fibromyalgia4

All 2 trials from Maastricht University →