Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-10 @ 4:40 PM
Study NCT ID:
NCT01811758
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2013-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Specific Interventions: African American Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2013-03-12', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day point prevalence abstinence', 'timeFrame': 'Overall effect at 12-months', 'description': 'Generalized linear mixed model of overall intervention effect.'}], 'secondaryOutcomes': [{'measure': '7-day point prevalence abstinence', 'timeFrame': '6-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Culturally Specific Cognitive Behavioral Therapy', 'Standard Cognitive Behavioral Therapy'], 'conditions': ['Smoking', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '25566367', 'type': 'BACKGROUND', 'citation': 'Hooper MW, Larry R, Okuyemi K, Resnicow K, Dietz NA, Robinson RG, Antoni MH. Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol. BMC Psychol. 2013 Aug 21;1(1):15. doi: 10.1186/2050-7283-1-15. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. self-identification as African American\n2. current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;\n3. age 18-65;\n4. able to speak and read English;\n5. permanent contact information;\n6. access to transportation by public transit or car;\n7. no current behavioral or pharmacological treatment ;\n8. interest in quitting smoking; (9) have availability to attend sessions.\n\nExclusion Criteria:\n\n1. enrolled in another cessation program,\n2. do not speak and read English,\n3. do not have access to transportation by car or bus to attend sessions,\n4. do not have childcare during session times,\n5. have contraindications for patch use (pregnant/breastfeeding),\n6. if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse),\n7. if they endorse active addiction to another substance (e.g., illicit drugs or alcohol),\n8. if they have been diagnosed with an acute cardiac or respiratory condition;\n9. people identified as having a severe mental illness'}, 'identificationModule': {'nctId': 'NCT01811758', 'acronym': 'SB2', 'briefTitle': 'Culturally Specific Interventions: African American Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Culturally Specific Interventions and Acculturation in African American Smokers', 'orgStudyIdInfo': {'id': 'SmokeBreak2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally Specific CBT', 'description': 'Culturally specific cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes. Up to 8-weeks of transdermal nicotine patches. Focused on African Americans: smoking patterns, health outcomes, discrimination, stress, weight concerns, cultural beliefs and practices.', 'interventionNames': ['Behavioral: Culturally Specific CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard CBT (control)', 'description': 'Standard cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes each. Up to 8-weeks of transdermal nicotine patches. Traditional CBT, with no focus on race: smoking and health, benefits of quitting, weight control, relapse prevention, coping skills.', 'interventionNames': ['Behavioral: Standard CBT']}], 'interventions': [{'name': 'Culturally Specific CBT', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Culturally Specific CBT']}, {'name': 'Standard CBT', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Standard CBT (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33124', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Monica Hooper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Monica W. Hooper', 'investigatorAffiliation': 'University of Miami'}}}}