Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT06288256
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current Opioid Misuse Measure (COMM) Score', 'timeFrame': 'Up to 12 months post-operatively', 'description': 'The Current Opioid Misuse Measure (COMM) is a 17-item self-report measure with total scores ranging from 0 to 68 that is used to identify risk of opioid misuse among chronic pain patients, with higher scores indicating higher risk of opioid misuse.'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS) Score', 'timeFrame': 'Up to 12 months post-operatively', 'description': "The Numerical Rating Scale (NRS) for pain intensity is an 11-point scale ranging from 0 to 10 that is used to measure a patient's self-reported pain intensity, with higher scores indicating more severe pain."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spine Pathology', 'Elective Spine Surgery']}, 'descriptionModule': {'briefSummary': 'Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.\n\nTo determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.\n\nThis is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'undergoing elective spine surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18\n* With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation\n\nExclusion Criteria:\n\n* Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation\n* Polytrauma\n* Prolonged hospitalization (\\>10days)\n* Pregnancy\n* Known surgery cancellation within study period'}, 'identificationModule': {'nctId': 'NCT06288256', 'briefTitle': 'Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery', 'orgStudyIdInfo': {'id': 'STUDY-22-01390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults Undergoing Spine Surgery', 'description': 'Adults Undergoing Spine Surgery on opiods', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Adults Undergoing Spine Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Spine Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Chinwe Nwaneshiudu, MD PhD', 'role': 'CONTACT', 'email': 'chinwe.nwaneshiudu@mountsinai.org', 'phone': '212-241-4203'}], 'overallOfficials': [{'name': 'Chinwe Nwaneshiudu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'CSR'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': "Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.\n\nFor individual participant data meta-analysis.\n\nProposals should be directed to chinwe.nwaneshiudu@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (TBD)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chinwe Nwaneshiudu', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}