[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622680":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":56,"interventions":69,"overallOfficials":76,"centralContacts":80,"locations":89,"responsibleParty":107,"collaborators":46,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":46,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":117,"maxAge":46,"enrollmentInfo":118,"targetDuration":46,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":46,"overallStatus":91,"whyStopped":46,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"University of California, San Diego","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Neurophysiological synchrony","Dyadic Neural Synchrony (DNS) across electrodes and dyads will be computed from EEG oscillations using established inter-brain connectivity metrics. DNS will be quantified as a dyadic coupling parameter computed from time-series features extracted from each participant's EEG activity. Higher DNS values indicate greater therapist-patient neural attunement.","During the intervention and for 5 minutes afterwards",[14,18,22,26,29,33,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Interpersonal Attunement","Interpersonal attunement measured by the Interpersonal Attunement Rating Scale, a 0-10 numeric rating scale to assess sense of connection with the other person (0=no attunement, 10=very high attunement).","During Intervention",{"measure":19,"description":20,"timeFrame":21},"Opioid Craving","Opioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).","Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up",{"measure":23,"description":24,"timeFrame":25},"Opioid Use","Days of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.","Pre-Intervention, and 1 month Follow-Up",{"measure":27,"description":28,"timeFrame":21},"Severity of Pain","Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)",{"measure":30,"description":31,"timeFrame":32},"Affect","Positive and negative affect measured on a 0-10 numeric rating scale (0=low affect, 10=very high affect).","Pre-Intervention, during Intervention, and immediately post-Intervention.",{"measure":34,"description":35,"timeFrame":36},"State Self-Transcendence","Nondual awareness measured by the Nondual Awareness Dimensional Assessment Measure- State (NADA-S), with scores ranging from 0 to 30, with higher scores indicating greater self-transcendence","Pre-Intervention, during Intervention, immediately post-Intervention.",{"measure":38,"description":39,"timeFrame":32},"Metacognitive processes","Metacognitive Processes of Decentering Scale (MPODS), a 3-Item scale with scores ranging from 0 to 30, with higher scores indicating greater capacity for meta-awareness, non-reactivity, and disidentification.",{"measure":41,"description":42,"timeFrame":12},"Cardiac-autonomic synchrony","Cardiac-autonomic synchrony (CAS) will be computed from heart rate variability. CAS will be quantified as a dyadic coupling parameter computed from time-series features extracted from each participant's R-R intervals. Higher CAS values indicate greater therapist-patient autonomic attunement.",{"measure":44,"description":45,"timeFrame":12},"Facial expression synchrony","Facial Expression Synchrony (FES) will be assessed using automated facial expression analysis derived from computer-vision-based facial landmark and action-unit detection. FES will be quantified as a dyadic coupling parameter computed from time-series features extracted from each participant's facial expressions. Higher FES values indicate greater therapist-patient affective attunement",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":52,"maskingDescription":46,"whoMasked":53},"DOUBLE",[54,55],"INVESTIGATOR","OUTCOMES_ASSESSOR",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"Meditation","EXPERIMENTAL","20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.",[62],"Behavioral: Meditation",{"label":64,"type":65,"description":66,"interventionNames":67},"Psychoeducation","ACTIVE_COMPARATOR","Psychoeducation about opioid neuropharmacology.",[68],"Behavioral: Psychoeducation",[70,73],{"type":71,"name":58,"description":60,"armGroupLabels":72,"otherNames":46},"BEHAVIORAL",[58],{"type":71,"name":64,"description":74,"armGroupLabels":75,"otherNames":46},"20 minute psychoeducational script on the impact of opioid use on the brain.",[64],[77],{"name":78,"affiliation":5,"role":79},"Eric Garland, PhD","PRINCIPAL_INVESTIGATOR",[81,86],{"name":82,"role":83,"phone":84,"phoneExt":46,"email":85},"Lori Kroh, BS","CONTACT","619-259-0735","l1kroh@health.ucsd.edu",{"name":87,"role":83,"phone":46,"phoneExt":46,"email":88},"Kelly Hendrickson, MS","kehendrickson@health.ucsd.edu",[90],{"facility":5,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"RECRUITING","La Jolla","California","92093","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-117.2742,32.84727,{"lat":101,"lon":100},[104],{"name":78,"role":83,"phone":105,"phoneExt":46,"email":106},"858-822-4092","egarland@health.ucsd.edu",{"type":79,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Eric Garland","Professor of Psychiatry","100622680","interpersonal-brain-function-in-opioid-use-100622680",false,"NCT07386769","Interpersonal Brain Function in Opioid Use","Inclusion Criteria:\n\n1. Persons, aged 18 or older\n2. Current near daily use of prescribed or illicit opioid agonists or mixed opioid agonist-antagonists for ≥90 days\n3. Must be able to speak and understand English\n\nExclusion Criteria:\n\n1. Cognitive Impairment that would preclude participation in the research protocol\n2. Active suicidal intent or psychosis","ALL","18 Years",{"count":119,"type":120},60,"ESTIMATED","INTERVENTIONAL",[123],"NA","The purpose of this study is to assess dyadic physiological coherence and subjective empathic attunement during meditation practices and their association with opioid-related outcomes.",[126],"People Who Use Opioids\u002FPeople With Opioid Use Disorder (OUD)","2026-01-29",{"date":129,"type":130},"2026-02-04","ACTUAL",{"date":132,"type":120},"2026-02-02",{"date":134,"type":120},"2027-05",{"name":5,"class":6},1]