Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 12:12 PM
Study NCT ID:
NCT00770666
Status:
COMPLETED
Last Update Posted:
2008-10-10
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Medications vs. Patch Alone for Medically-Ill Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-09', 'studyFirstSubmitDate': '2008-10-09', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tobacco use abstinence', 'timeFrame': '26 week'}], 'secondaryOutcomes': [{'measure': 'Time to first relapse', 'timeFrame': 'varies'}, {'measure': 'Duration of medication use', 'timeFrame': '26 weeks'}, {'measure': 'Adverse clinical events', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tobacco dependence treatment'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '37230961', 'type': 'DERIVED', 'citation': 'Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.'}, {'pmid': '19349630', 'type': 'DERIVED', 'citation': 'Steinberg MB, Greenhaus S, Schmelzer AC, Bover MT, Foulds J, Hoover DR, Carson JL. Triple-combination pharmacotherapy for medically ill smokers: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):447-54. doi: 10.7326/0003-4819-150-7-200904070-00004.'}]}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness', 'detailedDescription': 'Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))\n* 18 years or older\n* interested in quitting within the next 30 days\n* one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)\n\nExclusion Criteria:\n\n* contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)\n* current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications\n* unable to give consent'}, 'identificationModule': {'nctId': 'NCT00770666', 'briefTitle': 'Combination Medications vs. Patch Alone for Medically-Ill Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness', 'orgStudyIdInfo': {'id': '0220055373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Nicotine patch, nicotine inhaler, bupropion', 'interventionNames': ['Drug: Nicotine patch, nicotine inhaler, bupropion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Nicotine patch', 'interventionNames': ['Drug: Nicotine patch']}], 'interventions': [{'name': 'Nicotine patch, nicotine inhaler, bupropion', 'type': 'DRUG', 'description': 'Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily', 'armGroupLabels': ['1']}, {'name': 'Nicotine patch', 'type': 'DRUG', 'description': '21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Umdnj-Rwjms', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Michael B Steinberg, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMDNJ-RWJMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rutgers Cancer Institute of New Jersey', 'class': 'OTHER'}, {'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Michael Steinberg, MD, MPH', 'oldOrganization': 'UMDNJ-Robert Wood Johnson Medical School'}}}}