Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 4:18 PM
Study NCT ID:
NCT02301403
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2014-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Effectiveness RCT of Optimized Cessation Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sss@ctri.wisc.edu', 'phone': '6082627563', 'title': 'Stevens S. Smith, Ph.D.', 'organization': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.', 'description': 'Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?"\n\n* For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved.\n* For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.', 'eventGroups': [{'id': 'EG000', 'title': 'Modern Usual Care', 'description': 'Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).\n\nNicotine patch: 8 weeks of nicotine patch\n\nin-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website', 'otherNumAtRisk': 315, 'deathsNumAtRisk': 315, 'otherNumAffected': 66, 'seriousNumAtRisk': 315, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Abstinence-Optimized Cessation Treatment', 'description': 'There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.\n\nPreparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking\n\nCombination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt\n\nIntensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions\n\nExtended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions\n\nAutomated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 139, 'seriousNumAtRisk': 308, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching or Hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vivid Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent Indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Abstinence From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modern Usual Care', 'description': 'Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).\n\nNicotine patch: 8 weeks of nicotine patch\n\nin-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website'}, {'id': 'OG001', 'title': 'Abstinence-Optimized Cessation Treatment', 'description': 'There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.\n\nPreparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking\n\nCombination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt\n\nIntensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions\n\nExtended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions\n\nAutomated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '1.69', 'ciUpperLimit': '5.14', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post treatment', 'description': 'The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \\< 6 parts per million).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult smokers interested in quitting smoking who met inclusion and exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modern Usual Care', 'description': 'Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).\n\nNicotine patch: 8 weeks of nicotine patch\n\nin-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website'}, {'id': 'FG001', 'title': 'Abstinence-Optimized Cessation Treatment', 'description': 'There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.\n\nPreparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking\n\nCombination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt\n\nIntensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions\n\nExtended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions\n\nAutomated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '308'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '267'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '41'}]}]}], 'recruitmentDetails': 'Participants were patients from seven primary care clinics within two Wisconsin healthcare systems. Smokers who expressed interest in quitting smoking during a clinic visit were referred via the electronic health record (EHR) to the research study. Other smokers from these clinics were recruited via mailings and EHR messaging.', 'preAssignmentDetails': 'Primary care patients who passed the phone screen were invited to attend a study visit at their referring clinic to learn more about the study, have eligibility confirmed, and provide written informed consent. No enrolled participants were excluded from the study prior to assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Modern Usual Care', 'description': 'Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).\n\nNicotine patch: 8 weeks of nicotine patch\n\nin-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website'}, {'id': 'BG001', 'title': 'Abstinence-Optimized Cessation Treatment', 'description': 'There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.\n\nPreparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking\n\nCombination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt\n\nIntensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions\n\nExtended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions\n\nAutomated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '49.7', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-19', 'size': 1423401, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-05T15:00', 'hasProtocol': True}, {'date': '2014-12-09', 'size': 191828, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-03-05T15:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 623}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-11', 'studyFirstSubmitDate': '2014-11-21', 'resultsFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-03', 'studyFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Abstinence From Smoking', 'timeFrame': '6 months post treatment', 'description': 'The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \\< 6 parts per million).'}]}, 'conditionsModule': {'keywords': ['smoking', 'cessation', 'tobacco'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '30212849', 'type': 'RESULT', 'citation': 'Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.'}, {'pmid': '39868569', 'type': 'DERIVED', 'citation': 'Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.'}], 'seeAlsoLinks': [{'url': 'http://www.ctri.wisc.edu/', 'label': 'Description: University of Wisconsin Center for Tobacco Research and Intervention'}]}, 'descriptionModule': {'briefSummary': 'This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.', 'detailedDescription': 'The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>=18 years\n* smoking \\>4 cigarettes/day for the previous 6 months\n* able to read, write, and speak English\n* have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts\n* and if currently using NRT, agreeing to use only study medication for the duration of the study\n* we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses)\n* not currently attempting to quit smoking\n* not intending to quit smoking (defined as no plans to quit in the next month)\n* and planning to remain in the intervention catchment area for at least 12 months.\n\nExclusion Criteria:\n\n* currently taking bupropion or varenicline\n* medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days\n* diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years\n* and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.'}, 'identificationModule': {'nctId': 'NCT02301403', 'briefTitle': 'A Comparative Effectiveness RCT of Optimized Cessation Treatments', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Comparative Effectiveness RCT of Optimized Cessation Treatments', 'orgStudyIdInfo': {'id': '2014-1041 Cessation'}, 'secondaryIdInfos': [{'id': 'A534252', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\MEDICINE\\TOBACCO RE', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Modern Usual Care', 'description': 'Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).', 'interventionNames': ['Drug: Nicotine patch', 'Behavioral: in-person counseling and quitline counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Abstinence-Optimized Cessation Treatment', 'description': 'There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.', 'interventionNames': ['Drug: Preparation Nicotine Mini-Lozenges', 'Drug: Combination NRT (nicotine patch + nicotine mini-lozenges)', 'Behavioral: Intensive In-Person Cessation Counseling', 'Behavioral: Extended Maintenance Counseling Calls', 'Behavioral: Automated Adherence Calls']}], 'interventions': [{'name': 'Nicotine patch', 'type': 'DRUG', 'description': '8 weeks of nicotine patch', 'armGroupLabels': ['Modern Usual Care']}, {'name': 'in-person counseling and quitline counseling', 'type': 'BEHAVIORAL', 'description': 'a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website', 'armGroupLabels': ['Modern Usual Care']}, {'name': 'Preparation Nicotine Mini-Lozenges', 'type': 'DRUG', 'description': 'Nicotine lozenge prior to attempting to quit smoking', 'armGroupLabels': ['Abstinence-Optimized Cessation Treatment']}, {'name': 'Combination NRT (nicotine patch + nicotine mini-lozenges)', 'type': 'DRUG', 'description': '26 weeks of combination NRT as part of a quit smoking attempt', 'armGroupLabels': ['Abstinence-Optimized Cessation Treatment']}, {'name': 'Intensive In-Person Cessation Counseling', 'type': 'BEHAVIORAL', 'description': 'three 20-min In-person Cessation Counseling sessions', 'armGroupLabels': ['Abstinence-Optimized Cessation Treatment']}, {'name': 'Extended Maintenance Counseling Calls', 'type': 'BEHAVIORAL', 'description': '8 Maintenance-phase smoking cessation counseling sessions', 'armGroupLabels': ['Abstinence-Optimized Cessation Treatment']}, {'name': 'Automated Adherence Calls', 'type': 'BEHAVIORAL', 'description': '11 brief, automated calls reminding them to use their medications properly', 'armGroupLabels': ['Abstinence-Optimized Cessation Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53711', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Megan Piper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}