Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT01189305
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2010-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Behavioral Couples Therapy for Female Drug-Abusing Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent days abstinent from illicit drugs', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Abuse', 'Female Patients'], 'conditions': ['Drug Abuse']}, 'descriptionModule': {'briefSummary': 'In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients with primary drug abuse diagnosis \\& their relationship partners\n* patient married or cohabiting with relationship partner\n* partner without current alcohol or drug problem\n\nExclusion Criteria:\n\n* both patient and partner without severe mental health disorders'}, 'identificationModule': {'nctId': 'NCT01189305', 'acronym': 'CPW-D', 'briefTitle': 'Behavioral Couples Therapy for Female Drug-Abusing Patients', 'organization': {'class': 'OTHER', 'fullName': 'Harvard University'}, 'officialTitle': 'Behavioral Couples Therapy for Female Drug-Abusing Patients', 'orgStudyIdInfo': {'id': '1R01DA025618', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA025618', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01DA025618', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA025618', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Couples Therapy', 'interventionNames': ['Behavioral: Behavioral Couples Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Individual Drug Counseling', 'interventionNames': ['Behavioral: Individual Drug Counseling']}], 'interventions': [{'name': 'Behavioral Couples Therapy', 'type': 'BEHAVIORAL', 'description': 'Behavioral Couples Therapy', 'armGroupLabels': ['Behavioral Couples Therapy']}, {'name': 'Individual Drug Counseling', 'type': 'BEHAVIORAL', 'description': 'Individual Drug Counseling', 'armGroupLabels': ['Individual Drug Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'AdCare Hospital of Worcester Inc.', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': "Timothy J O'Farrell, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology', 'investigatorFullName': "Timothy J. O'Farrell", 'investigatorAffiliation': 'Harvard University'}}}}