Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-04-17 @ 1:08 PM
Study NCT ID:
NCT01887366
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
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': 'C000604228', 'term': 'TV-1380'}]}}, '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': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'dispFirstSubmitDate': '2015-10-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-12', 'studyFirstSubmitDate': '2013-06-24', 'dispFirstSubmitQcDate': '2015-10-12', 'studyFirstSubmitQcDate': '2013-06-24', 'dispFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine test for cocaine', 'timeFrame': 'Treatment Phase weeks 10 - 12'}], 'secondaryOutcomes': [{'measure': 'Percent of urine samples that are considered negative for cocaine metabolites.', 'timeFrame': 'Treatment Phase Weeks 5 -12'}, {'measure': 'Summary of participants with adverse events', 'timeFrame': 'From signing of the informed consent form to the end of the follow-up period (Week 16)'}]}, 'conditionsModule': {'keywords': ['Cocaine addiction', 'TV-1380', 'Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)'], 'conditions': ['Cocaine Addiction']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy and safety of TV-1380 \\[Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)\\] in facilitating abstinence in cocaine-dependent subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.\n* Male or female aged 18-60 years (inclusive).\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.\n* Other criteria apply; please contact the site for more information.\n\nExclusion Criteria:\n\n* Meet criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana OR have physiological dependence on alcohol requiring detoxification.\n* Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening.\n* Have one or more severe psychiatric disorders as determined by the Mini International Neuropsychiatric Interview (MINI) such as psychosis, schizophrenia, bipolar disease, major depression, or eating disorders in screening.\n* Have one or more major neurologic disorders such as dementia or organic brain disease.\n* Have other serious medical illnesses (including but not limited to uncontrolled hypertension, significant heart disease, respiratory disease including asthma, hepatic disease, renal disease, AIDS) or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site MD.\n* Other criteria apply; please contact the site for more information.'}, 'identificationModule': {'nctId': 'NCT01887366', 'briefTitle': 'Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A 12-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Once-Weekly Intra-Muscular Injections of TV-1380 (150 mg/Week or 300 mg/Week) as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects', 'orgStudyIdInfo': {'id': 'TV1380-COA-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TV-1380 150 mg', 'interventionNames': ['Drug: TV-1380 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'TV-1380 300 mg', 'interventionNames': ['Drug: TV-1380 300 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TV-1380 150 mg', 'type': 'DRUG', 'otherNames': ['Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)'], 'description': 'Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents).', 'armGroupLabels': ['TV-1380 150 mg']}, {'name': 'TV-1380 300 mg', 'type': 'DRUG', 'otherNames': ['Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)'], 'description': 'Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380.', 'armGroupLabels': ['TV-1380 300 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10663', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10665', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10659', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10746', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 10664', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 10661', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 10668', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 10747', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vagas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Teva Investigational Site 10745'}, {'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 10667', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 10662', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 10660', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 10658', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 10666', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Teva Investigational Site 31064', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Teva Investigational Site 31063', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Teva Investigational Site 31065', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Teva Investigational Site 31069', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Teva Investigational Site 31068', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}