protocolSection identificationModule nctId: NCT06355414, orgStudyIdInfo id: IRB00385932, secondaryIdInfos id: R33AT012317, type: NIH, link: https://reporter.nih.gov/quickSearch/R33AT012317, briefTitle: Psilocybin in Chronic Low Back Pain and Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2026-08-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D).Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects., conditionsModule conditions: Chronic Low-back Pain, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, active control study comparing the effects of psilocybin (25mg fixed dose) and methylphenidate (40mg fixed dose), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: This is a double-blind trial, and efforts will be made to mask the study drug (psilocybin) and the active control (methylphenidate) from participants, guides, and study staff. Participants will be debriefed about their randomly assigned drug condition after the completion of the final follow-up assessment, or after discontinuation/withdrawal, whichever comes first., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Methylphenidate, outcomesModule primaryOutcomes measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), primaryOutcomes measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), primaryOutcomes measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA), primaryOutcomes measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing), secondaryOutcomes measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), secondaryOutcomes measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), secondaryOutcomes measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA), secondaryOutcomes measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing), otherOutcomes measure: Pain as assessed by discrete pain items assessed via EMA, otherOutcomes measure: Dynamic association between affect and pain using micro-longitudinal EMA data of affective variables (positive, negative affect outcomes) and pain outcomes, otherOutcomes measure: Changes in mood as measured by a selection of discrete items derived from the Positive and Negative Affect Schedule- Expanded Form (PANAS-X)., otherOutcomes measure: Changes in self-reported Pain Impact as measured by Pain intensity (P), interference with Enjoyment of life (E), and interference with General activity (G) Scale (PEG), otherOutcomes measure: Changes in Pressure Pain Threshold (Quantitative Sensory Testing), otherOutcomes measure: Changes in Conditioned Pain Modulation (Quantitative Sensory Testing), otherOutcomes measure: Chronic Pain Exacerbation as measured by the Graded Chronic Pain Scale- Revised (GCPS-R), otherOutcomes measure: Changes in neuropathic pain features as assessed by the painDETECT questionnaire (PDQ), otherOutcomes measure: Changes in CLBP-related disability as measured by the Oswestry Disability Index (ODI), otherOutcomes measure: Change in Emotion Regulation as assessed by the Difficulties in Emotion Regulation Scale (DERS), otherOutcomes measure: Pain intensity and related dimensions of health (i.e., sleep) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.0)., otherOutcomes measure: Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale (PIPS), otherOutcomes measure: Personal values and the degree of success in following those values as measured by the Chronic Pain Values Inventory (CPVI)., otherOutcomes measure: Dispositional tendencies to feel positive emotions towards others in daily life as measured by the Dispositional Positive Emotion Scale (DPES), otherOutcomes measure: Mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ-15), otherOutcomes measure: Subjective experiences: Awe Experience Scale (AWE-S), otherOutcomes measure: Subjective experiences: Mystical Experience Questionnaire (MEQ30), otherOutcomes measure: Subjective experiences: Challenging Experience Questionnaire (CEQ), otherOutcomes measure: Subjective experiences: Altered States of Consciousness Questionnaire (5D-ASC), otherOutcomes measure: Subjective experiences: Psychological Insight Questionnaire (PIQ), otherOutcomes measure: Changes in basic beliefs about the world as measured by the Primals Inventory (PI-6), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins University School of Medicine, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: David Yaden, PhD, role: CONTACT, phone: 410-550-5250, phoneExt: 0-5250, email: dyaden1@jhmi.edu, contacts name: David Yaden, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Patrick Finan, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False