Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-07 @ 5:18 AM
Study NCT ID:
NCT00497302
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2007-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Housing For Drug Dependent Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-01', 'studyFirstSubmitDate': '2007-07-05', 'studyFirstSubmitQcDate': '2007-07-05', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment retention, drug free urine samples at follow-up and delivery', 'timeFrame': 'treatment entry until 12 months post treatment entry'}], 'secondaryOutcomes': [{'measure': 'prenatal care compliance, neonatal and birth outcomes', 'timeFrame': 'treatment entry until 12 months post treatment entry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cocaine', 'opiate', 'pregnancy', 'post-partum', 'neonatal abstinence syndrome', 'contingency management', 'Reinforcement Based Treatment', 'women'], 'conditions': ['Drug Addiction']}, 'descriptionModule': {'briefSummary': 'For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. The present project proposes to extend this treatment intervention to the special population of pregnant drug using women enrolled at the Center for Addiction and Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent recovery house living plus intensive individual therapy, to standard care at the CAP program. Specific aims of the project are derived from testing a two-group design are described below:\n\n1. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention.\n2. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.\n3. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling results in better maternal and infant clinical birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical complications).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CAP enrolled\n* Age 18 or older\n* Evidence of use of opiate and/or cocaine use in the past 30 days\n* Assigned to pharmacotherapy free modality\n* CAP admission at an estimated gestational age (EGA) \\<34 weeks\n\nExclusion criteria:\n\n* Endorses current suicidal ideation\n* Any medical disorders requiring extended or future hospitalization\n* Meet diagnostic criteria for current DSM-IV alcohol dependence\n* Meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)\n* Demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery'}, 'identificationModule': {'nctId': 'NCT00497302', 'acronym': 'HOME', 'briefTitle': 'Recovery Housing For Drug Dependent Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Recovery Housing For Drug Dependent Pregnant Women', 'orgStudyIdInfo': {'id': 'R01DA014979', 'link': 'https://reporter.nih.gov/quickSearch/R01DA014979', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA014979', 'link': 'https://reporter.nih.gov/quickSearch/R01DA014979', 'type': 'NIH'}, {'id': 'DPMCDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'receives housing based on drug abstinence', 'interventionNames': ['Behavioral: RBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Usual care treatment at the Center for Addiction and Pregnancy', 'interventionNames': ['Behavioral: usual care']}], 'interventions': [{'name': 'RBT', 'type': 'BEHAVIORAL', 'description': 'Contingency management and behavioral counseling including motivational interviewing', 'armGroupLabels': ['1']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'description': 'receives usual comprehensive care at Center for Addiction and Pregnancy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Hendree E Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor', 'investigatorFullName': 'Hendree E. Jones', 'investigatorAffiliation': 'Johns Hopkins University'}}}}