Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:28 PM
Study NCT ID:
NCT07386769
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interpersonal Brain Function in Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurophysiological synchrony', 'timeFrame': 'During the intervention and for 5 minutes afterwards', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Interpersonal Attunement', 'timeFrame': 'During Intervention', 'description': '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).'}, {'measure': 'Opioid Craving', 'timeFrame': 'Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up', 'description': 'Opioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).'}, {'measure': 'Opioid Use', 'timeFrame': 'Pre-Intervention, and 1 month Follow-Up', 'description': 'Days of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.'}, {'measure': 'Severity of Pain', 'timeFrame': 'Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up', 'description': 'Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)'}, {'measure': 'Affect', 'timeFrame': 'Pre-Intervention, during Intervention, and immediately post-Intervention.', 'description': 'Positive and negative affect measured on a 0-10 numeric rating scale (0=low affect, 10=very high affect).'}, {'measure': 'State Self-Transcendence', 'timeFrame': 'Pre-Intervention, during Intervention, immediately post-Intervention.', 'description': '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'}, {'measure': 'Metacognitive processes', 'timeFrame': 'Pre-Intervention, during Intervention, and immediately post-Intervention.', 'description': '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': 'Cardiac-autonomic synchrony', 'timeFrame': 'During the intervention and for 5 minutes afterwards', 'description': "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': 'Facial expression synchrony', 'timeFrame': 'During the intervention and for 5 minutes afterwards', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['People Who Use Opioids/People With Opioid Use Disorder (OUD)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07386769', 'briefTitle': 'Interpersonal Brain Function in Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Interpersonal Brain Function in Opioid Use', 'orgStudyIdInfo': {'id': '813632'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation', 'description': '20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.', 'interventionNames': ['Behavioral: Meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation', 'description': 'Psychoeducation about opioid neuropharmacology.', 'interventionNames': ['Behavioral: Psychoeducation']}], 'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL', 'description': '20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.', 'armGroupLabels': ['Meditation']}, {'name': 'Psychoeducation', 'type': 'BEHAVIORAL', 'description': '20 minute psychoeducational script on the impact of opioid use on the brain.', 'armGroupLabels': ['Psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Garland, PhD', 'role': 'CONTACT', 'email': 'egarland@health.ucsd.edu', 'phone': '858-822-4092'}], 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Lori Kroh, BS', 'role': 'CONTACT', 'email': 'l1kroh@health.ucsd.edu', 'phone': '619-259-0735'}, {'name': 'Kelly Hendrickson, MS', 'role': 'CONTACT', 'email': 'kehendrickson@health.ucsd.edu'}], 'overallOfficials': [{'name': 'Eric Garland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will become available after the publication of the main study findings from the final data set. Data will be made permanently available.', 'ipdSharing': 'YES', 'description': 'The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.', 'accessCriteria': 'Data will be made available upon reasonable request with a signed data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Eric Garland', 'investigatorAffiliation': 'University of California, San Diego'}}}}