Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-02-20 @ 6:08 PM
Study NCT ID:
NCT00067535
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2003-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2003-08-21', 'studyFirstSubmitQcDate': '2003-08-22', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic response to cocaine and subjective response to cocaine', 'timeFrame': '3x / 30 days'}]}, 'conditionsModule': {'keywords': ['cocaine dependence'], 'conditions': ['Cocaine-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681', 'detailedDescription': 'Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIncludes but is not limited to:\n\n* Non-treatment seekers\n* DSM-IV criteria for cocaine abuse or dependence\n* Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements\n\nExclusion Criteria:\n\nPlease contact site for more information.'}, 'identificationModule': {'nctId': 'NCT00067535', 'briefTitle': 'Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Potential Interactions Between IV Cocaine and RPR 102681', 'orgStudyIdInfo': {'id': 'NIDA-CPU-0003-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cocaine-Related Disorders', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814 4799', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Uniformed Services University of Health Science', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Louis Cantilena, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uniformed Services University of Health Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}}}}