The Impact of Psilocybin on Pain in Fibromyalgia Patients

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMaastricht University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin

    Drug

    Each participant will receive 2 different doses of psilocybin (5mg and 10mg) and a matching placebo on three separate occasions.

  • Hypnosis script

    Behavioral

    All participants will receive a brief hypnotic induction aimed at producing analgesia before the second administration of CPT

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Patient groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Ischemic Pain perception

Pain tolerance (seconds) in the Cold Pressor Task

Time frame
1.5, 2.5 and 4 hours after administration
2

Pressure-evoked Pain perception

Pain threshold (kPa) in the Pressure Pain Threshold

Time frame
1.5 and 4 hours after administration
3

Self-reported pain

Painfulness Visual Analogue Scale (0: no pain; 10 worst pain)

Time frame
1.5, 2.5 and 4 hours after administration

Secondary outcomes

1

Subjective effects: psychedelic phenomenology

5 Dimensions of altered states of consciousness (5D-ASC)

Time frame
Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after administration
2

Subjective effects: mood

Profile of mood states (POMS)

Time frame
Baseline, 1, 2, 3, and 5 hours after administration
3

Subjective effects: intensity of effects

Intensity of effects Visual Analogue Scale (VAS) (0: not under the influence; 10: very much under the influence)

Time frame
Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after administration
4

Subjective effects: Ego dissolution

Ego Dissolution Inventory(EDI)

Time frame
6 hours after administration

Other outcomes

Sponsors and contacts

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Maastricht University

Lead sponsor

Leiden University Medical Center

Collaborator