Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 6:16 PM
Study NCT ID:
NCT00033033
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2002-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reserpine for the Treatment of Cocaine Dependence - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012110', 'term': 'Reserpine'}], 'ancestors': [{'id': 'D015016', 'term': 'Yohimbine'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2003-05'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2002-04-05', 'studyFirstSubmitQcDate': '2002-04-05', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cocaine use'}, {'measure': 'Addiction severity'}, {'measure': 'Cocaine withdrawal'}, {'measure': 'Adverse events'}, {'measure': 'Clinical improvement'}]}, 'conditionsModule': {'keywords': ['cocaine dependence'], 'conditions': ['Cocaine-Related Disorders', 'Substance-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '25969833', 'type': 'DERIVED', 'citation': 'Winhusen TM, Lewis DF, Somoza EC, Horn P. Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial. ISRN Addict. 2014 Feb 5;2014:927290. doi: 10.1155/2014/927290. eCollection 2014.'}, {'pmid': '25938124', 'type': 'DERIVED', 'citation': 'Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.', 'detailedDescription': 'To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBe at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method\n\nExclusion Criteria:\n\nAdditional criteria available during screening at the site.'}, 'identificationModule': {'nctId': 'NCT00033033', 'briefTitle': 'Reserpine for the Treatment of Cocaine Dependence - 1', 'nctIdAliases': ['NCT00024869'], 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence', 'orgStudyIdInfo': {'id': 'NIDA-CTO-0001-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Reserpine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati VA Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45428', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton VA Medical Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}], 'overallOfficials': [{'name': 'Eugene Somoza, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cincinnati VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'collaborators': [{'name': 'Cincinnati VA Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Liza Gorgon / Clinical Trials Specialist', 'oldOrganization': 'NIDA'}}}}