Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-21 @ 8:22 AM
Study NCT ID:
NCT02861820
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2016-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Connectivity Changes During Early Recovery as a Marker for Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-14', 'size': 535779, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-16T11:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain connectivity', 'timeFrame': 'Change from Baseline, to 2 months', 'description': '3T MRI scan'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fMRI', 'brain networks', 'biomarker', 'relapse', 'stimulants'], 'conditions': ['Substance Use Disorder']}, 'descriptionModule': {'briefSummary': 'The study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. More specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery. This study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult individuals with Substance Use Disorder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 but no more than 45 years old at the time of consent.\n* Able to provide written consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, HIV).\n* Any contraindications to MRI scanning (i.e. metal implants, pacemakers, etc.).\n* Intellectual developmental disorder as defined in the DSM-V. Participant may have a diagnosis of an Axis I disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable.\n* Actively suicidal.\n* Positive screen for alcohol and/or drugs. Participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again.\n* Evidence for Wernicke-Korsakoff syndrome.\n* Healthy Controls may never have had any form of substance use disorder other than caffeine or nicotine. Nicotine use will be recorded but will not be an exclusion criterion.'}, 'identificationModule': {'nctId': 'NCT02861820', 'briefTitle': 'Functional Connectivity Changes During Early Recovery as a Marker for Relapse', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Functional Connectivity Changes During Early Recovery as a Marker for Relapse', 'orgStudyIdInfo': {'id': 'PSYCH-2016-24183'}, 'secondaryIdInfos': [{'id': '1R01DA038984-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA038984-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Substance Use Disorder (SUD)', 'description': 'Participants in the SUD group will:\n\n* Complete a diagnostic screening interview at baseline.\n* Complete questionnaires and computer tasks at baseline, 1 month and 2 month time points.\n* Complete MRI brain imaging data collection at the baseline, 1 month and 2 month time points.\n* Complete 9 follow-up phone calls to assess for relapse.', 'interventionNames': ['Device: MRI: Brain Imaging Data Collection']}, {'label': 'Healthy Control (HC)', 'description': 'Participants in the HC group will:\n\n* Complete a diagnostic screening interview at baseline.\n* Complete questionnaires and computer tasks at baseline and 2 month time points.\n* Complete MRI brain imaging data collection at the baseline and 2 month time points.', 'interventionNames': ['Device: MRI: Brain Imaging Data Collection']}], 'interventions': [{'name': 'MRI: Brain Imaging Data Collection', 'type': 'DEVICE', 'description': 'This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.', 'armGroupLabels': ['Healthy Control (HC)', 'Substance Use Disorder (SUD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Kelvin O Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'As requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}