Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-04-23 @ 8:45 AM
Study NCT ID:
NCT02416050
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Relapse After Cocaine Inpatient Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean difference of fractional anisotropy of the prefrontal cortex (PFC) in patients abstinent from cocaine 3 months after inpatient detoxification compared to relapsers', 'timeFrame': 'at 3 months'}], 'secondaryOutcomes': [{'measure': 'Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse', 'timeFrame': 'at baseline', 'description': 'Differences in grey and white matter volumes : voxel-based morphometry (VBM) and in resting-state whole-brain activity default mode network (DMN)'}, {'measure': 'Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse', 'timeFrame': 'at baseline', 'description': 'Differences in scores of craving (visual scale and Obsessive compusilve craving scale (OCCS) questionnaire) and impulsivity (UPPS)'}, {'measure': 'Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse', 'timeFrame': 'at baseline', 'description': 'Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task'}, {'measure': 'Among abstinent patients who remain abstinent at three months only :Differences between baseline and 3 months measures of Diffusion Tensor Imagery (DTI), VBM and DMN', 'timeFrame': 'at 3 months'}, {'measure': 'Among abstinent patients who remain abstinent at three months only: Differences in scores of craving (visual scale and OCCS questionnaire) and impulsivity (UPPS)', 'timeFrame': 'at 3 months'}, {'measure': 'Among abstinent patients who remain abstinent at three months only: Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task compared to baseline results', 'timeFrame': 'at 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cocaine', 'Dependence', 'Abstinence', 'Prediction', 'Model', 'Humans', 'MRI', 'Cognitive', 'Impulsivity', 'Craving'], 'conditions': ['Cocaine Dependence', 'Cocaine Use Disorder']}, 'descriptionModule': {'briefSummary': 'Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated with relapse to cocaine use.', 'detailedDescription': 'A multivariate model using MRI parameters, craving score, impulsivity score, and neuropsychological testing results will be tested to predict relapse or continuous abstinence three month after cocaine inpatient cessation attempt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cocaine dependent patient requiring inpatient cessation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cocaine dependent patient requiring inpatient cessation\n* 18 years old and older\n* giving his/her consent to come back for visits up to three months\n* having a social insurance\n\nExclusion Criteria:\n\n* minor\n* under guardianship\n* restraint hospitalization\n* contraindication to brain MRI\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02416050', 'acronym': 'QUIT-COC', 'briefTitle': 'Predicting Relapse After Cocaine Inpatient Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures', 'orgStudyIdInfo': {'id': 'P120125'}, 'secondaryIdInfos': [{'id': '2014-A01169-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Brain MRI imagery', 'type': 'PROCEDURE', 'description': 'Brain MRI performed during the first week of inpatient cocaine cessation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Psychiatrie, Hôpital Fernand Widal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Florence VORSPAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}