Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-04-01 @ 9:39 AM
Study NCT ID:
NCT04261504
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2019-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yiyuan@asu.edu', 'phone': '4807903577', 'title': 'Yi-Yuan Tang', 'organization': 'Arizona State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Integrative Body Mind Training (IBMT)', 'description': 'mindfulness\n\nIBMT: mindful presence in a non-judgmental way', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Relaxation Training (RT)', 'description': 'relaxation\n\nRT: progressive muscle relaxation', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Changes in Functional Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrative Body Mind Training (IBMT)', 'description': 'mindfulness\n\nIBMT: mindful presence in a non-judgmental way'}, {'id': 'OG001', 'title': 'Relaxation Training (RT)', 'description': 'relaxation\n\nRT: progressive muscle relaxation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold p\\<0.05.', 'statisticalMethod': 'threshold-free cluster enhancement', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The outcome measure is assessed at baseline and post-intervention.', 'description': '70 participants with polysubstance use are assessed by changes of brain in functional activity of anterior cingulate cortex before (baseline) and post-intervention (2 weeks).', 'unitOfMeasure': 'beta weights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Integrative Body Mind Training (IBMT)', 'description': 'mindfulness\n\nIBMT: mindful presence in a non-judgmental way'}, {'id': 'FG001', 'title': 'Relaxation Training (RT)', 'description': 'relaxation\n\nRT: progressive muscle relaxation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Integrative Body Mind Training (IBMT)', 'description': 'mindfulness\n\nIBMT: mindful presence in a non-judgmental way'}, {'id': 'BG001', 'title': 'Relaxation Training (RT)', 'description': 'relaxation\n\nRT: progressive muscle relaxation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Not Reported Ethnicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-21', 'size': 715703, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-03-29T12:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2019-12-22', 'resultsFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-08', 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Changes in Functional Activity', 'timeFrame': 'The outcome measure is assessed at baseline and post-intervention.', 'description': '70 participants with polysubstance use are assessed by changes of brain in functional activity of anterior cingulate cortex before (baseline) and post-intervention (2 weeks).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Drug Use']}, 'descriptionModule': {'briefSummary': 'The proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) on alcohol, tobacco, and cannabis (ATC) reduction.', 'detailedDescription': 'The R61 phase of the proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) that targets at self-control networks in the brain, and test IBMT effects on alcohol, tobacco, and cannabis (ATC) reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) at least 18 years old;\n* (2) free of any psychiatric diagnoses or medication (besides a substance use disorder to alcohol, tobacco, or cannabis);\n* (3) in the past month, at least 4 episode of heavy episodic drinking; at least 3 occasion of cannabis use; and daily cigarette use for at least the past month;\n* (4) normal or corrected-to-normal vision;\n* (5) written informed consent;\n* (6) no previous meditation or neurofeedback (NF) experiences.\n\nExclusion Criteria:\n\n* (1) any psychiatric diagnoses other than a substance use disorder;\n* (2) medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females);\n* (3) excluding cannabis, evidence of recent (past month) illicit drug use.'}, 'identificationModule': {'nctId': 'NCT04261504', 'briefTitle': 'Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention', 'orgStudyIdInfo': {'id': 'IRB2018-943'}, 'secondaryIdInfos': [{'id': 'R61AT010138', 'link': 'https://reporter.nih.gov/quickSearch/R61AT010138', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrative Body Mind Training (IBMT)', 'description': 'mindfulness', 'interventionNames': ['Behavioral: IBMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation Training (RT)', 'description': 'relaxation', 'interventionNames': ['Behavioral: RT']}], 'interventions': [{'name': 'IBMT', 'type': 'BEHAVIORAL', 'description': 'mindful presence in a non-judgmental way', 'armGroupLabels': ['Integrative Body Mind Training (IBMT)']}, {'name': 'RT', 'type': 'BEHAVIORAL', 'description': 'progressive muscle relaxation', 'armGroupLabels': ['Relaxation Training (RT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79409', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'TTU/UT', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Yi-Yuan Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}