Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-26 @ 11:53 PM
Study NCT ID:
NCT01393457
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2011-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Remediation for Cocaine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'C046649', 'term': 'ropinirole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles.green@uth.tmc.edu', 'phone': '713-500-6402', 'title': 'Charles Green, PhD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'weekly for 10 weeks', 'description': 'Side effects were not considered to be adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Ldopa + Ropinirole Low Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 2 mg/d: 2 mg/d', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ldopa + Ropinirole High Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 4 mg/d: 4 mg/d', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Ldopa', 'description': 'levodopa/carbidopa 800/200 mg/d', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout flare up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cocaine Use Based on Urine Drug Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ldopa + Ropinirole Low Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 2 mg/d: 2 mg/d'}, {'id': 'OG001', 'title': 'Ldopa + Ropinirole High Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 4 mg/d: 4 mg/d'}, {'id': 'OG002', 'title': 'Ldopa', 'description': 'levodopa/carbidopa 800/200 mg/d'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '20.36', 'spread': '29.51', 'groupId': 'OG000'}, {'value': '15.57', 'spread': '21.96', 'groupId': 'OG001'}, {'value': '22.3', 'spread': '28', 'groupId': 'OG002'}, {'value': '27.8', 'spread': '30.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.', 'unitOfMeasure': 'number of negative drug screens', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Completed the 10 Week Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ldopa + Ropinirole Low Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 2 mg/d: 2 mg/d'}, {'id': 'OG001', 'title': 'Ldopa + Ropinirole High Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 4 mg/d: 4 mg/d'}, {'id': 'OG002', 'title': 'Ldopa', 'description': 'levodopa/carbidopa 800/200 mg/d'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ldopa + Ropinirole Low Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 2 mg/d: 2 mg/d'}, {'id': 'FG001', 'title': 'Ldopa + Ropinirole High Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 4 mg/d: 4 mg/d'}, {'id': 'FG002', 'title': 'Ldopa', 'description': 'levodopa/carbidopa 800/200 mg/d'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': '119 were enrolled (that is, signed the consent); however, only 110 were randomized. Of the 9 that were not enrolled but not randomized, 1 was no longer interested after signing the consent, and 8 were lost to follow up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ldopa + Ropinirole Low Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 2 mg/d: 2 mg/d'}, {'id': 'BG001', 'title': 'Ldopa + Ropinirole High Dose', 'description': 'levodopa/carbidopa: 800/200 mg/d\n\nRopinirole 4 mg/d: 4 mg/d'}, {'id': 'BG002', 'title': 'Ldopa', 'description': 'levodopa/carbidopa 800/200 mg/d'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.96', 'spread': '6.50', 'groupId': 'BG000'}, {'value': '46.04', 'spread': '8.70', 'groupId': 'BG001'}, {'value': '48', 'spread': '7.87', 'groupId': 'BG002'}, {'value': '47.11', 'spread': '8.56', 'groupId': 'BG003'}, {'value': '46.6', 'spread': '7.93', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of days of cocaine use over the last 30 days', 'classes': [{'categories': [{'measurements': [{'value': '16.12', 'spread': '8.08', 'groupId': 'BG000'}, {'value': '16.31', 'spread': '9.64', 'groupId': 'BG001'}, {'value': '17.19', 'spread': '8.46', 'groupId': 'BG002'}, {'value': '14.74', 'spread': '8.69', 'groupId': 'BG003'}, {'value': '16.13', 'spread': '8.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-09-02', 'size': 1360951, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-23T11:24', 'hasProtocol': True}, {'date': '2011-09-02', 'size': 227416, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-23T11:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2011-07-11', 'resultsFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-23', 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cocaine Use Based on Urine Drug Screening', 'timeFrame': '10 weeks', 'description': 'The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Completed the 10 Week Trial', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cocaine', 'cognition', 'medication', 'treatment'], 'conditions': ['Cocaine Dependence']}, 'referencesModule': {'references': [{'pmid': '34600245', 'type': 'DERIVED', 'citation': 'Suchting R, Green CE, de Dios C, Vincent J, Moeller FG, Lane SD, Schmitz JM. Citalopram for treatment of cocaine use disorder: A Bayesian drop-the-loser randomized clinical trial. Drug Alcohol Depend. 2021 Nov 1;228:109054. doi: 10.1016/j.drugalcdep.2021.109054. Epub 2021 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet criteria for cocaine dependence\n* seeking treatment for cocaine dependence\n* be in acceptable health based on medical history and physical exam\n\nExclusion Criteria:\n\n* dependent on drugs other than cocaine, nicotine, marijuana\n* have a medical condition contraindicating treatment with study medications\n* having conditions of probation or parole requiring reports of drug use to officers of the court'}, 'identificationModule': {'nctId': 'NCT01393457', 'briefTitle': 'Cognitive Remediation for Cocaine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Cognitive-enhancing DA Medications for Cocaine Dependence', 'orgStudyIdInfo': {'id': 'DA030787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ldopa + ropinirole low dose', 'description': 'levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d', 'interventionNames': ['Drug: levodopa/carbidopa', 'Drug: Ropinirole 2 mg/d']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ldopa + ropinirole high dose', 'description': 'levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d', 'interventionNames': ['Drug: levodopa/carbidopa', 'Drug: Ropinirole 4 mg/d']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ldopa', 'description': 'levodopa/carbidopa 800/200 mg/d', 'interventionNames': ['Drug: levodopa/carbidopa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'levodopa/carbidopa', 'type': 'DRUG', 'otherNames': ['ldopa'], 'description': '800/200 mg/d', 'armGroupLabels': ['ldopa', 'ldopa + ropinirole high dose', 'ldopa + ropinirole low dose']}, {'name': 'Ropinirole 2 mg/d', 'type': 'DRUG', 'otherNames': ['Requip'], 'description': '2 mg/d', 'armGroupLabels': ['ldopa + ropinirole low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'sugar pill', 'armGroupLabels': ['placebo']}, {'name': 'Ropinirole 4 mg/d', 'type': 'DRUG', 'otherNames': ['Requip'], 'description': '4 mg/d', 'armGroupLabels': ['ldopa + ropinirole high dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77045', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Behavioral and Biomedical Sciences Building', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Psychiatry', 'investigatorFullName': 'Joy Schmitz', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}