Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-07 @ 5:46 PM
Study NCT ID:
NCT03007394
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lorcaserin in the Treatment of Cocaine Use Disorder
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': 'C506658', 'term': 'lorcaserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmccann@nida.nih.gov', 'phone': '301-827-5934', 'title': 'David McCann, Ph.D.', 'organization': 'National Institute on Drug Abuse'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected every week during treatment and through study follow-up, a 13-week treatment phase with a 4-week follow-up period.', 'description': '1. The "Intent-to-Treat (ITT) Population" of 272 are all subjects who may have taken at least one dose of lorcaserin or placebo after randomization as noted in the total for the participant flow.\n2. The "PPEE Population" of 242 is the subset of the ITT Population who pre-qualify for the primary efficacy endpoint by meeting the specified PPEE criteria prior to randomization, which is the subset population used here', 'eventGroups': [{'id': 'EG000', 'title': 'Lorcaserin', 'description': '10 mg capsule by mouth, twice a day, for 13 weeks\n\nLorcaserin: Lorcaserin Capsule', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 66, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo Oral Capsule', 'description': '10 mg placebo capsule, twice a day, for 13 weeks\n\nPlacebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 69, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Blood pressure increase/decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression/Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bodily injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Life threatening and hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Life threatening and hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': '10 mg capsule by mouth, twice a day, for 13 weeks\n\nLorcaserin: Lorcaserin Capsule'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': '10 mg placebo capsule, twice a day, for 13 weeks\n\nPlacebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment weeks 11 - 13', 'description': 'Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': '10 mg capsule by mouth, twice a day, for 13 weeks\n\nLorcaserin: Lorcaserin Capsule'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': '10 mg placebo capsule, twice a day, for 13 weeks\n\nPlacebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment weeks 11-13', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lorcaserin', 'description': '10 mg capsule by mouth, twice a day, for 13 weeks\n\nLorcaserin: Lorcaserin Capsule'}, {'id': 'FG001', 'title': 'Placebo Oral Capsule', 'description': '10 mg placebo capsule, twice a day, for 13 weeks\n\nPlacebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '63'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lorcaserin', 'description': '10 mg capsule by mouth, twice a day, for 13 weeks\n\nLorcaserin: Lorcaserin Capsule'}, {'id': 'BG001', 'title': 'Placebo Oral Capsule', 'description': '10 mg placebo capsule, twice a day, for 13 weeks\n\nPlacebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '9.88', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '9.99', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '9.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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': '77', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The "Intent-to-Treat (ITT) Population" of 272 are all subjects who may have taken at least one dose of lorcaserin or placebo after randomization.\n\n2\\) The "PPEE Population" of 242 is the subset of the ITT Population who pre-qualify for the primary efficacy endpoint by meeting the specified PPEE criteria prior to randomization'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-17', 'size': 1014320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-02T10:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2016-12-21', 'resultsFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2016-12-28', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-02', 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population', 'timeFrame': 'Treatment weeks 11 - 13', 'description': 'Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.'}], 'secondaryOutcomes': [{'measure': 'The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence', 'timeFrame': 'Treatment weeks 11-13'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cocaine Use Disorder'], 'conditions': ['Cocaine-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.', 'detailedDescription': 'This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5\n* Is seeking treatment for cocaine use disorder\n* Is able to understand and provide written informed consent\n* Has used cocaine on at least 1 day in the last 30 days prior to screening\n* Has completed all psychological assessments and procedures during the screening period\n* If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control\n* Has a total body weight greater than 110 pounds and body mass index greater than 20\n\nExclusion Criteria:\n\n* Contact site for more information'}, 'identificationModule': {'nctId': 'NCT03007394', 'briefTitle': 'Lorcaserin in the Treatment of Cocaine Use Disorder', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder', 'orgStudyIdInfo': {'id': 'NIDA/VACSP #1033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lorcaserin', 'description': '10 mg capsule by mouth, twice a day, for 13 weeks', 'interventionNames': ['Drug: Lorcaserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Capsule', 'description': '10 mg placebo capsule, twice a day, for 13 weeks', 'interventionNames': ['Drug: Placebo Oral Capsule']}], 'interventions': [{'name': 'Lorcaserin', 'type': 'DRUG', 'otherNames': ['Belviq', 'lorcaserin hydrochloride'], 'description': 'Lorcaserin Capsule', 'armGroupLabels': ['Lorcaserin']}, {'name': 'Placebo Oral Capsule', 'type': 'DRUG', 'description': 'sugar pill to mimic lorcaserin 10mg capsule', 'armGroupLabels': ['Placebo Oral Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92307', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Treatment and Research Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90016', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Matrix Institute on Addictions', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92660-2452', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Behavioral Clinical Research, Inc.', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '02118-2391', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Altea Research Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neuro-Behavioral Clinical Research Inc.', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97214', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'CODA, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Shwe Gyaw, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute on Drug Abuse (NIDA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}