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The Impact of Psilocybin on Pain in Fibromyalgia Patients

NCT06368492 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Psilocybin

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

BEHAVIORAL

Hypnosis script

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

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Maastricht University

    lead OTHER

Principal Investigators

  • Johannes G. Ramaekers, PhD · Maastricht University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368492 on ClinicalTrials.gov