Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01281202
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vigabatrin for the Treatment of Cocaine Dependency
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': 'D020888', 'term': 'Vigabatrin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmccann@nida.nih.gov', 'phone': '301-443-2999', 'title': 'David McCann, Ph.D.', 'organization': 'National Institute on Drug Abuse'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CPP-109 Vigabatrin Tablets', 'description': 'Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.', 'otherNumAtRisk': 103, 'otherNumAffected': 84, 'seriousNumAtRisk': 103, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received Vigabatrin placebo table orally once daily for 7 weeks.', 'otherNumAtRisk': 104, 'otherNumAffected': 89, 'seriousNumAtRisk': 104, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of conciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPP-109 Vigabatrin Tablets', 'description': 'Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.\n\nSubjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.\n\nSubjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8-9', 'description': 'The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPP-109 Vigabatrin Tablets', 'description': 'Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase\n\nDuring treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks\n\nSubjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase\n\nDuring treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks\n\nSubject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)'}], 'classes': [{'title': 'Week 3', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3 - 9', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CPP-109 Vigabatrin Tablets', 'description': 'Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received Vigabatrin placebo table orally once daily for 7 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CPP-109 Vigabatrin Tablets', 'description': 'Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received Vigabatrin placebo table orally once daily for 7 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '47.2', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '46.6', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2011-01-20', 'resultsFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-19', 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence', 'timeFrame': 'Weeks 8-9', 'description': 'The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Cocaine Use', 'timeFrame': 'Week 3 - 9'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cocaine', 'Cocaine Addiction Treatment', 'Cocaine Treatment', 'Vigabatrin', 'CPP-109', 'Catalyst', 'National Institute on Drug Abuse'], 'conditions': ['Cocaine Addiction', 'Cocaine Dependence']}, 'descriptionModule': {'briefSummary': "The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.", 'detailedDescription': "The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.\n\nThere are 3 Phases to this study:\n\n* a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested;\n* a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and\n* a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand the study and provide written informed consent.\n* Male or female at least 18 years of age.\n* Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module.\n* Have a verifiable place of primary residence.\n* Seeking treatment for cocaine dependence.\n* Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings.\n* If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable.\n\nExclusion Criteria:\n\n* Please contact site for more information'}, 'identificationModule': {'nctId': 'NCT01281202', 'briefTitle': 'Vigabatrin for the Treatment of Cocaine Dependency', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study', 'orgStudyIdInfo': {'id': 'CPP-01005/CS# 1030 TRANSFERRED'}, 'secondaryIdInfos': [{'id': 'Y1-DA4006', 'type': 'OTHER_GRANT', 'domain': 'NIDA/VA CSP #1030'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPP-109 Vigabatrin Tablets', 'description': 'Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase\n\nDuring treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks\n\nSubjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)', 'interventionNames': ['Drug: Vigabatrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase\n\nDuring treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks\n\nSubjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'Vigabatrin', 'type': 'DRUG', 'otherNames': ['CPP-109', 'GVG', 'VGB'], 'description': 'Tablets', 'armGroupLabels': ['CPP-109 Vigabatrin Tablets']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90016', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Matrix Institute on Addictions', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Friends Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'NeuroPsychiatric Research & Practice Assoc., Ltd.', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mountain Manor Treatment Center @ Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Pacific Institute for Research and Evaluation', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Inst. and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pillar Clinical Research, LLC', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'George E Wahlen VA Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Kathleen Brady, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Christopher J Stock, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'George E. Wahlen VA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalyst Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'VA Office of Research and Development', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}