Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00877435
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-28', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retention in treatment, cocaine abstinence', 'timeFrame': '24 weeks', 'description': 'cocaine abstinence: at least 3 consecutive weeks of cocaine abstinence, the maximum number of weeks of continous abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up.'}], 'secondaryOutcomes': [{'measure': "patients' satisfaction with the therapy, clinical measures", 'timeFrame': '24 weeks', 'description': "patients' satisfaction with prize-based contingency management and with CBT"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cocaine-related Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.upkbs.ch', 'label': 'Psychiatric Hospital of the University of Basel - Addiction Research Unit'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first trial of this type in Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cocaine dependence, aged 18 or older, other dependences\n\nExclusion Criteria:\n\n* severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate'}, 'identificationModule': {'nctId': 'NCT00877435', 'briefTitle': 'Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SNF-105314-120675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM)', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (CBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Cognitive behavioral therapy (CBT)', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (CBT)']}], 'interventions': [{'name': 'Cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4025', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitäre Psychiatrischen Kliniken', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1221', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Fondation Phenix', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Sylvie A Petitjean, Dr. phil.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatric Hospital of the University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. phil', 'investigatorFullName': 'Sylvie Petitjean', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}