Clinical TrialFibromyalgiaPsilocybinPlaceboRecruiting

The Impact of Psilocybin on Pain in Fibromyalgia Patients (PsiloFM)

This double-blind, randomized, placebo-controlled trial (n=35) will investigate the impact of psilocybin (5–10 mg) on pain perception in fibromyalgia patients.

Target Enrollment
35 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This within-subject, double-blind, randomized placebo-controlled study will test two low doses of oral psilocybin (5 mg and 10 mg) versus placebo in 35 fibromyalgia patients to assess effects on experimental pain sensitivity (Cold Pressor Test and Pressure Pain Threshold).

Participants attend five visits over five weeks including screening/familiarization, three dosing sessions (placebo, 5 mg, 10 mg, randomized order) with experimental tasks, blood sampling and questionnaires, and a final online follow-up; a brief hypnotic induction is applied before one CPT to test moderation of analgesic response.

Study Protocol

Preparation

1 sessions

Dosing

3 sessions

Integration

1 sessions

Study Arms & Interventions

Psilocybin crossover

experimental

Within-subject, randomized crossover: each participant receives placebo, 5 mg and 10 mg psilocybin in randomized order; brief hypnotic induction before second CPT.

Interventions

  • Psilocybin5 - 10 mg
    via Oral• single dose• 3 doses total

    Oral capsules; 5 mg and 10 mg arms administered in randomized order

  • Placebo
    via Oral• single dose

    Matching placebo capsule

  • Compound
    via Other• single dose

    Brief hypnotic induction aimed at producing analgesia before the second CPT (behavioral intervention)

Participants

Ages
18 – 65
Sexes
Male & Female

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
  • A minimum 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 allowed and one rescue therapy permitted as specified)
  • 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 before study sessions and during study days
  • Willingness not to drive or 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 screening
  • 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

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment35 participants
  • Timeline
    Start: 2024-04-01
    End: 2025-12-31
  • Compounds
    PsilocybinPlacebo
  • Topic
    Fibromyalgia

Locations

Maastricht University — Maastricht, Limburg, Netherlands
Leiden University Medical Center — Leiden, South Holland, Netherlands

Your Library