protocolSection identificationModule nctId: NCT06368492, orgStudyIdInfo id: P137, secondaryIdInfos id: 2021-002909-10, type: EUDRACT_NUMBER, secondaryIdInfos id: NL78008.068.21, type: OTHER, domain: METC azM/Maastricht University, briefTitle: The Impact of Psilocybin on Pain in Fibromyalgia Patients, acronym: PsiloFM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Maastricht University, class: OTHER, collaborators name: Leiden University Medical Center, descriptionModule briefSummary: 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., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: double-blind, randomized, within-subjects, placebo-controlled design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinding will be handled by one of the study pharmacies and order and allocation of the treatment to each participant will be completely randomized. This setup ensures that neither the participant nor the experimenter running the test day will be aware of the contents of the capsule., enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Hypnosis script, outcomesModule primaryOutcomes measure: Ischemic Pain perception, primaryOutcomes measure: Pressure-evoked Pain perception, primaryOutcomes measure: Self-reported pain, secondaryOutcomes measure: Subjective effects: psychedelic phenomenology, secondaryOutcomes measure: Subjective effects: mood, secondaryOutcomes measure: Subjective effects: intensity of effects, secondaryOutcomes measure: Subjective effects: Ego dissolution, secondaryOutcomes measure: Subjective effects: Dissociation, secondaryOutcomes measure: Psychiatric symptoms, secondaryOutcomes measure: Cognitive performance, secondaryOutcomes measure: Vigilance, secondaryOutcomes measure: Empathy, secondaryOutcomes measure: Creativity, secondaryOutcomes measure: Creativity, secondaryOutcomes measure: Autobiographical memory, secondaryOutcomes measure: Autobiographical memory, secondaryOutcomes measure: Treatment expectancy, secondaryOutcomes measure: Treatment expectancy, secondaryOutcomes measure: Fibromyalgia-related pain, secondaryOutcomes measure: Personality, secondaryOutcomes measure: Absorption, secondaryOutcomes measure: Interpersonal Reactivity, secondaryOutcomes measure: Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University, city: Maastricht, state: Limburg, zip: 6226AK, country: Netherlands, contacts name: Mauro Cavarra, MSc, role: CONTACT, phone: +313494438261, email: m.cavarra@maastrichtuniversity.nl, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Leiden University Medical Center, city: Leiden, state: South Holland, zip: 2333, country: Netherlands, contacts name: Monique van Velzen, PhD, role: CONTACT, email: M.van_Velzen@lumc.nl, geoPoint lat: 52.15833, lon: 4.49306, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-08, uploadDate: 2023-10-30T07:36, filename: Prot_SAP_000.pdf, size: 673739, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-10, uploadDate: 2023-10-30T07:38, filename: ICF_001.pdf, size: 451492, hasResults: False