Clinical TrialFibromyalgiaPsilocybinPsilocybinPlaceboRecruiting

The Impact of Psilocybin on Pain in Fibromyalgia Patients and Healthy Volunteers: a Multicenter Trial

Double-blind, randomised Phase II trial (n=44) comparing single oral low doses of psilocybin (5 mg, 10 mg) versus placebo to assess effects on pain tolerance and painfulness in fibromyalgia patients and healthy volunteers.

Target Enrollment
44 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled multicentre trial (single site in the Netherlands) with three arms (psilocybin 5 mg, psilocybin 10 mg, matched placebo) evaluating pain tolerance and subjective painfulness in fibromyalgia patients and healthy volunteers.

Primary outcomes include pain tolerance (seconds), pressure pain threshold and subjective painfulness ratings measured at 1.5 and 4 hours post-administration; secondary outcomes cover mood, cognition, personality and psychedelic experience with follow-up assessments.

Participants must meet BMI and diagnostic criteria (fibromyalgia group) or have no major medical/psychiatric conditions (healthy volunteers); placebo capsules are matched to active psilocybin capsules.

Study Arms & Interventions

Psilocybin 5 mg

experimental

Single oral capsule of 5 mg psilocybin versus placebo.

Interventions

  • Psilocybin5 mg
    via Oral• single dose

    Capsule (5 mg)

Psilocybin 10 mg

experimental

Single oral capsule of 10 mg psilocybin versus placebo.

Interventions

  • Psilocybin10 mg
    via Oral• single dose

    Capsule (10 mg)

Placebo

inactive

Matched oral capsule placebo.

Interventions

  • Placebo
    via Oral• single dose

    Matched capsule placebo

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Fibromyalgia patients:
  • Age 18–65 years
  • BMI 18–28 kg/m2
  • Fulfilment of the American College of Rheumatology criteria for fibromyalgia
  • Minimum NRS pain score ≥5/10
  • Proficient in English; written informed consent
  • Understanding of procedures and risks
  • Free from or discontinued psychotropic medication (e.g., opiates, antidepressants, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines) at least 5 days before the study
  • Non-pharmacological regimens allowed; one rescue analgesic permitted (acetaminophen ≤4,000 mg/day; ibuprofen ≤1,200 mg/day; naproxen ≤660 mg/day; ketoprofen ≤75 mg/day)
  • Willingness to refrain from psychoactive substances during the study
  • Alcohol-free and no coffee, black or green tea, or energy drinks after midnight before study days and during study days
  • Willingness not to drive or operate machines within 24 h after administration
  • Healthy volunteers:
  • Age 18–65 years
  • BMI 18–28 kg/m2
  • Proficient in English; written informed consent
  • Absence of major medical or psychiatric condition on exam and labs
  • Free from psychotropic medication
  • Willingness to refrain from psychoactive substances during the study
  • Alcohol-free and no coffee, black or green tea, or energy drinks after midnight before study days and during study days
  • Willingness not to drive or operate machines within 24 h after administration

Exclusion Criteria

  • Fibromyalgia patients:
  • Presence of other painful conditions (e.g., inflammatory rheumatic disease, migraine) or other chronic/acute medical conditions
  • Presence or history of primary major depressive disorder, anxiety disorders, or substance use disorder
  • Previous serious adverse reaction to psychedelic drugs (e.g., severe anxiety, panic)
  • Tobacco smoking >20/day
  • Excessive alcohol use (>20 consumptions/week)
  • Psychotic disorder in first-degree relatives
  • Pregnancy or lactation
  • Hypertension (systolic >140 mmHg or diastolic >90 mmHg)
  • History of cardiac dysfunction (arrhythmia, ischemic heart disease)
  • For women: not using reliable contraception
  • Healthy volunteers:
  • History of drug addiction
  • Previous serious adverse reaction to psychedelic drugs
  • Pregnancy or lactation
  • Hypertension (systolic >140 mmHg or diastolic >90 mmHg)
  • Current or past psychiatric disorder
  • Psychotic disorder in first-degree relatives
  • Any chronic or acute medical condition
  • History of cardiac dysfunction (e.g., arrhythmia, ischemic heart disease)
  • For women: not using reliable contraception
  • Tobacco smoking >20/day
  • Excessive alcohol use (>20 consumptions/week)

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment44 participants
  • Timeline
    Start: 2021-12-22
    End: 2024-12-31
  • Compounds
    PsilocybinPsilocybinPlacebo
  • Topic
    Fibromyalgia

Locations

Netherlands

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