Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00000293
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
1999-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
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': 'C051752', 'term': 'nefazodone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 0}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2001-12'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '1999-09-20', 'studyFirstSubmitQcDate': '1999-09-20', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention'}, {'measure': 'Primary drug use'}, {'measure': 'Depression (secondary)'}, {'measure': 'Relapse'}]}, 'conditionsModule': {'keywords': ['cocaine dependence'], 'conditions': ['Cocaine-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.', 'detailedDescription': 'The purpose of this study is to determine the effect of nefazodone on relapse to cocaine in women and if a greater effect will be seen in the dependent condition. A relapse and coping skills questionnaire will be utilized to determine the various factors important to the relapse process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale, ages 18-55, cocaine abuse/dependence, use of cocaine 7 days of the last 30 days or of the 30 days prior to current abstinence, less than 90 days current abstinence, at least an 8th grade education.\n\nExclusion Criteria:\n\nUnstable medical conditions; current use of Hismanal, Seldane, or Propulsid; dx of MR, OBS, bipolar, schizophrenia.'}, 'identificationModule': {'nctId': 'NCT00000293', 'briefTitle': 'Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Effect of Nefazodone on Relapse in Females With Cocaine Abuse', 'orgStudyIdInfo': {'id': 'NIDA-09259-10'}, 'secondaryIdInfos': [{'id': 'P50-09259-10'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Nefazodone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Dorothy Hatsukami, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}]}}}