Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-26 @ 3:05 PM
Study NCT ID:
NCT00497068
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2007-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tobacco Use in Opioid Agonist Treated Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-06', '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': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score', 'timeFrame': 'from treatment entry until 6 weeks post-partum'}], 'secondaryOutcomes': [{'measure': 'tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters', 'timeFrame': 'from treatment entry to 6 weeks posrt-partum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking', 'pregnancy', 'neonatal abstinence syndrome'], 'conditions': ['Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '22352784', 'type': 'DERIVED', 'citation': "Tuten M, Svikis DS, Keyser-Marcus L, O'Grady KE, Jones HE. Lessons learned from a randomized trial of fixed and escalating contingency management schedules in opioid-dependent pregnant women. Am J Drug Alcohol Abuse. 2012 Jul;38(4):286-92. doi: 10.3109/00952990.2011.643977. Epub 2012 Feb 22."}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed pregnancy\n* Treatment entry at or before 31 weeks EGA\n* Expected to enter drug-free outpatient modality at CAP\n* Placed on methadone pharmacotherapy\n* Nicotine dependent\n* Sufficient literacy and understanding for assessment procedures\n* Expected availability for study duration (e.g., complete inpatient stay)\n* Able and willing to provide informed consent\n* At least 18 years of age\n* Confirmed smoker of 10 or more cigarettes\n\nExclusion Criteria:\n\n* Not pregnant\n* EGA of 32 weeks or greater\n* 17 years of age or younger\n* Undergoing detoxification (non-methadone treatment)\n* Unable to provide informed consent\n* Currently receiving nicotine replacement products (NRT)\n* Current diagnosis of alcohol or benzodiazepine dependence\n* Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.'}, 'identificationModule': {'nctId': 'NCT00497068', 'acronym': 'ROSE', 'briefTitle': 'Tobacco Use in Opioid Agonist Treated Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Tobacco Use in Opioid Agonist Treated Pregnant Women', 'orgStudyIdInfo': {'id': 'R01DA012403', 'link': 'https://reporter.nih.gov/quickSearch/R01DA012403', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA012403', 'link': 'https://reporter.nih.gov/quickSearch/R01DA012403', 'type': 'NIH'}, {'id': 'DPMCDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tobacco abstinent contingent voucher', 'description': 'Tobacco abstinent contingent voucher condition', 'interventionNames': ['Behavioral: tobacco abstinent contingent']}, {'type': 'EXPERIMENTAL', 'label': 'non-contingent', 'description': 'Participants receive vouchers non-contingent upon tobacco use status', 'interventionNames': ['Behavioral: non-contingent']}, {'type': 'OTHER', 'label': 'no voucher', 'description': 'This is the standard care intervention', 'interventionNames': ['Behavioral: control']}], 'interventions': [{'name': 'tobacco abstinent contingent', 'type': 'BEHAVIORAL', 'description': 'Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence', 'armGroupLabels': ['tobacco abstinent contingent voucher']}, {'name': 'non-contingent', 'type': 'BEHAVIORAL', 'description': 'Participants receive vouchers regardless of tobacco use status', 'armGroupLabels': ['non-contingent']}, {'name': 'control', 'type': 'BEHAVIORAL', 'description': 'this group receives no vouchers', 'armGroupLabels': ['no voucher']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy', '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'}}}}