Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 7:33 AM
Study NCT ID:
NCT01684995
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivation and Nicotine Patch Treatment for Under-served 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'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '1999-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '24044880', 'type': 'DERIVED', 'citation': 'Bock B, Lopes CE, van den Berg JJ, Roberts MB, Stein LA, Martin RA, Martin SA, Clarke JG. Social support and smoking abstinence among incarcerated adults in the United States: a longitudinal study. BMC Public Health. 2013 Sep 17;13:859. doi: 10.1186/1471-2458-13-859.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. The defined population comprises low income, less educated smokers who will vary in their level of motivation to quit smoking. Patients will be randomly assigned within clinics to one of two interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored motivational intervention, a behavioral skills counseling session for smoking cessation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Currently smoking at least 10 cigarettes/day for past 3 months\n* Speak English or Spanish\n* Have a telephone or live close to a relative or neighbor with a telephone\n* Agree to participate in the study and be available over the next 6 months.\n\nExclusion Criteria:\n\n* Unable to use nicotine patch due to medical status\n* Active skin condition or history of skin allergy\n* Currently using smokeless tobacco, nicotine replacement or other smoking cessation treatment\n* Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01684995', 'briefTitle': 'Motivation and Nicotine Patch Treatment for Under-served Smokers', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Motivation and Nicotine Patch Treatment for Under-served Smokers', 'orgStudyIdInfo': {'id': 'Quit_RIte_RI'}, 'secondaryIdInfos': [{'id': 'R01DA010860', 'link': 'https://reporter.nih.gov/quickSearch/R01DA010860', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Minimal', 'description': 'Brief physician advice to quit smoking plus nicotine patch', 'interventionNames': ['Behavioral: Brief physician advice', 'Drug: nicotine patch']}, {'type': 'EXPERIMENTAL', 'label': 'Tailored', 'interventionNames': ['Behavioral: Brief physician advice', 'Drug: nicotine patch', 'Behavioral: Individually Tailored Behavioral Skills training']}], 'interventions': [{'name': 'Brief physician advice', 'type': 'BEHAVIORAL', 'description': 'Brief physician advice to quit smoking', 'armGroupLabels': ['Minimal', 'Tailored']}, {'name': 'nicotine patch', 'type': 'DRUG', 'description': 'nicotine patch', 'armGroupLabels': ['Minimal', 'Tailored']}, {'name': 'Individually Tailored Behavioral Skills training', 'type': 'BEHAVIORAL', 'description': 'Individually tailored behavioral skills training for smoking cessation', 'armGroupLabels': ['Tailored']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}