Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-09 @ 1:57 AM
Study NCT ID:
NCT02191033
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Text Messaging for Smoking Cessation in College Health Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deepa.camenga@yale.edu', 'phone': '203-737-8310', 'title': 'Deepa Camenga, MD', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a pilot and feasibility study.'}}, 'adverseEventsModule': {'timeFrame': 'From January 2015 through August 2016', 'eventGroups': [{'id': 'EG000', 'title': 'Text Messaging', 'description': 'Smoking counseling, nicotine patch, text messaging\n\nSmoking counseling\n\nNicotine patch\n\nText messaging', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Smoking counseling, nicotine patch\n\nSmoking counseling\n\nNicotine patch', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Study Enrollment- Number of Participants Who Join the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Smoking counseling, nicotine patch, text messaging\n\nSmoking counseling\n\nNicotine patch\n\nText messaging'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Smoking counseling, nicotine patch\n\nSmoking counseling\n\nNicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': 'We will report the number of persons who join the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Smoking counseling, nicotine patch, text messaging\n\nSmoking counseling\n\nNicotine patch\n\nText messaging'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Smoking counseling, nicotine patch\n\nSmoking counseling\n\nNicotine patch'}], 'classes': [{'title': '6-week retention', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '12-week retention', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6- and 12- weeks', 'description': 'We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Smoking counseling, nicotine patch, text messaging\n\nSmoking counseling\n\nNicotine patch\n\nText messaging'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Smoking counseling, nicotine patch\n\nSmoking counseling\n\nNicotine patch'}], 'classes': [{'title': '6-week', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '12-week', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6- and 12- weeks', 'description': 'biochemically confirmed point prevalence of self reported past 7-day abstinence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Text Messaging', 'description': 'Smoking counseling, nicotine patch, text messaging\n\nSmoking counseling\n\nNicotine patch\n\nText messaging'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Smoking counseling, nicotine patch\n\nSmoking counseling\n\nNicotine patch'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment open from January 2015 to May 2016. Recruited from local college campuses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Text Messaging', 'description': 'Smoking counseling, nicotine patch, text messaging\n\nSmoking counseling\n\nText messaging\n\nNicotine patch'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Smoking counseling, nicotine patch\n\nSmoking counseling\n\nNicotine patch'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '20.5', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '20.2', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'American Indian/Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2014-07-08', 'resultsFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-27', 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Enrollment- Number of Participants Who Join the Study', 'timeFrame': 'baseline', 'description': 'We will report the number of persons who join the study.'}, {'measure': 'Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.', 'timeFrame': '6- and 12- weeks', 'description': 'We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.'}], 'secondaryOutcomes': [{'measure': 'Smoking Abstinence', 'timeFrame': '6- and 12- weeks', 'description': 'biochemically confirmed point prevalence of self reported past 7-day abstinence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cigarette smoking', 'tobacco use cessation products'], 'conditions': ['Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college.\n\nThe primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 through 24 years\n* Enrolled as a full/part time college student\n* A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days)\n* English-speaking\n* Interested in quitting\n* Have a cell phone for personal use with an unlimited text messaging plan.\n\nExclusion Criteria:\n\n* History of hypersensitivity/allergy to nicotine patch;\n* Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease)\n* Current pregnancy/breastfeeding/plan for pregnancy'}, 'identificationModule': {'nctId': 'NCT02191033', 'briefTitle': 'Text Messaging for Smoking Cessation in College Health Clinics', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics', 'orgStudyIdInfo': {'id': '1404013813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text messaging', 'description': 'Smoking counseling, nicotine patch, text messaging', 'interventionNames': ['Behavioral: Smoking counseling', 'Behavioral: Text messaging', 'Drug: Nicotine patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Smoking counseling, nicotine patch', 'interventionNames': ['Behavioral: Smoking counseling', 'Drug: Nicotine patch']}], 'interventions': [{'name': 'Smoking counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Standard of care', 'Text messaging']}, {'name': 'Text messaging', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Text messaging']}, {'name': 'Nicotine patch', 'type': 'DRUG', 'armGroupLabels': ['Standard of care', 'Text messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06515', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Southern Connecticut State University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Deepa R Camenga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Connecticut State University', 'class': 'UNKNOWN'}, {'name': 'University of New Haven', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}