Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01050569
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2010-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Innovative Interventions for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hatsu001@umn.edu', 'phone': '612 626-2121', 'title': 'Dorothy Hatsukami', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains \\<0.1 mg of nicotine yield.', 'otherNumAtRisk': 79, 'otherNumAffected': 60, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VLNC Cigarette Plus Nicotine Patch', 'description': 'VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.', 'otherNumAtRisk': 76, 'otherNumAffected': 56, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nicotine Patch', 'description': '21 mg nicotine patch', 'otherNumAtRisk': 80, 'otherNumAffected': 54, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 42, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 55, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 29, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stomach Ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Shakiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Belching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 26, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sleep Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 100, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 90, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 29, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'End of Treatment Abstinence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VLNC Cigarette', 'description': 'VLNC Cigarettes: Cigarette where the tobacco contains \\<0.1 mg nicotine yield.'}, {'id': 'OG001', 'title': 'VLNC Cigarette Plus Nicotine Patch', 'description': 'Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.'}, {'id': 'OG002', 'title': 'Nicotine Patch', 'description': '21 mg nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 week', 'description': 'Cotinine and carbon monoxide (CO) verified point prevalence abstinence', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'End of Follow-up Abstinence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains \\<0.1 mg of nicotine yield.'}, {'id': 'OG001', 'title': 'VLNC Cigarette Plus Nicotine Patch', 'description': 'Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.'}, {'id': 'OG002', 'title': 'Nicotine Patch', 'description': '21 mg nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 weeks', 'description': 'CO- and cotinine-verified point prevalence abstinence', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exposure to Tobacco Toxicants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains \\<0.1 mg of nicotine yield.'}, {'id': 'OG001', 'title': 'VLNC Cigarette Plus Nicotine Patch', 'description': 'Very Low Nicotine Content Cigarette Plus Nicotine Patch : 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.'}, {'id': 'OG002', 'title': 'Nicotine Patch', 'description': '21 mg nicotine patch'}], 'classes': [{'title': 'Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-buta', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.55'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.36'}, {'value': '0.25', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.34'}]}]}, {'title': 'Total Nicotine Exposure (TNE)', 'categories': [{'measurements': [{'value': '6.89', 'groupId': 'OG000', 'lowerLimit': '4.26', 'upperLimit': '11.02'}, {'value': '27.39', 'groupId': 'OG001', 'lowerLimit': '17.29', 'upperLimit': '43.38'}, {'value': '23.10', 'groupId': 'OG002', 'lowerLimit': '14.59', 'upperLimit': '36.60'}]}]}, {'title': 'Cotinine', 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '1.20', 'upperLimit': '3.45'}, {'value': '7.65', 'groupId': 'OG001', 'lowerLimit': '4.59', 'upperLimit': '12.76'}, {'value': '5.50', 'groupId': 'OG002', 'lowerLimit': '3.31', 'upperLimit': '9.13'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'pmol/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Lapse or Relapse to Tobacco Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains \\<0.1 mg of nicotine yield.'}, {'id': 'OG001', 'title': 'VLNC Plus Nicotine Patch', 'description': 'Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.'}, {'id': 'OG002', 'title': 'Nicotine Patch', 'description': '21 mg nicotine patch'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '5.9'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '7.7'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '26 weeks', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains \\<0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.'}, {'id': 'FG001', 'title': 'VLNC Cigarette Plus Nicotine Patch', 'description': 'Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.'}, {'id': 'FG002', 'title': 'Nicotine Patch', 'description': 'Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Oct 2008 to September 2011 Location was at the University of Minnesota Twin Cities and Duluth, Minnesota', 'preAssignmentDetails': 'After signing consent and before randomization to groups, 44 were lost to follow-up, 17 were ineligible, 10 were no longer interested, 10 were family members of enrollees.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains \\<0.1 mg of nicotine yield.'}, {'id': 'BG001', 'title': 'VLNC Cigarette Plus Nicotine Patch', 'description': 'VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.'}, {'id': 'BG002', 'title': 'Nicotine Patch', 'description': '21 mg nicotine patch'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '47.0', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '47.3', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '47.0', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2010-01-14', 'resultsFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-14', 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End of Treatment Abstinence Rate', 'timeFrame': '12 week', 'description': 'Cotinine and carbon monoxide (CO) verified point prevalence abstinence'}, {'measure': 'End of Follow-up Abstinence Rates', 'timeFrame': '36 weeks', 'description': 'CO- and cotinine-verified point prevalence abstinence'}], 'secondaryOutcomes': [{'measure': 'Exposure to Tobacco Toxicants', 'timeFrame': '6 weeks'}, {'measure': 'Time to Lapse or Relapse to Tobacco Use', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Nicotine Free Cigarettes'], 'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '23603206', 'type': 'RESULT', 'citation': "Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19."}, {'pmid': '25192771', 'type': 'DERIVED', 'citation': 'Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.', 'detailedDescription': 'The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.\n\nThe following primary hypothesis will be tested:\n\nAbstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.\n\nOther hypotheses include:\n\n1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;\n2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and\n3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.\n\nCigarette smokers will be randomized to:\n\n1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;\n2. Nicotine patch for 6 weeks; or\n3. VLNC cigarettes alone.\n\nOutcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a) Smoking at least 10 cigarettes daily for the past year;\n* b) In good physical health;\n* c) No contraindications for medicinal nicotine; and\n* d) Stable, good mental health.\n\nExclusion Criteria:\n\n* a) Subjects must not be using other tobacco or nicotine products.\n* b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.'}, 'identificationModule': {'nctId': 'NCT01050569', 'briefTitle': 'Innovative Interventions for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone', 'orgStudyIdInfo': {'id': '0409M63686'}, 'secondaryIdInfos': [{'id': '1R01DA025598', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA025598', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VLNC Cigarette', 'description': 'Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.', 'interventionNames': ['Other: VLNC Cigarette']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Patch', 'description': '21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.', 'interventionNames': ['Drug: Nicotine Patch']}, {'type': 'EXPERIMENTAL', 'label': 'VLNC Cigarette plus Nicotine Patch', 'description': 'Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks', 'interventionNames': ['Other: VLNC Cigarette Plus Nicotine Patch']}], 'interventions': [{'name': 'Nicotine Patch', 'type': 'DRUG', 'otherNames': ['Nicoderm CQ'], 'description': '21 mg', 'armGroupLabels': ['Nicotine Patch']}, {'name': 'VLNC Cigarette', 'type': 'OTHER', 'otherNames': ['Quest 3', 'Xodus'], 'description': 'Cigarette where the tobacco contains \\<0.1 mg of nicotine yield.', 'armGroupLabels': ['VLNC Cigarette']}, {'name': 'VLNC Cigarette Plus Nicotine Patch', 'type': 'OTHER', 'otherNames': ['Nicoderm CQ', 'Quest 3', 'Xodus'], 'description': '21 mg nicotine patch plus use of cigarette with tobacco containing \\<0.1 mg nicotine yield.', 'armGroupLabels': ['VLNC Cigarette plus Nicotine Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55812', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "University of MN's Tobacco Use Research Center", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Dorothy Hatsukami, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}