Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-04 @ 4:49 PM
Study NCT ID:
NCT03164668
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kotly001@umn.edu', 'phone': '612-625-1160', 'title': 'Michael Kotlyar', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)", 'description': 'Adverse events rated as possibly, probably or definitely related to being in the study', 'eventGroups': [{'id': 'EG000', 'title': 'Avoid Menthol Cigarettes; Receive Menthol E-cigarettes', 'description': 'Participants avoid smoking menthol cigarettes and receive menthol flavored e-cigarettes', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes', 'description': 'Participants avoid smoking menthol cigarettes and receive tobacco flavored e-cigarettes', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Cigarettes; Receive Menthol E-cigarettes', 'description': 'Participants can continue to smoke their usual cigarettes and receive menthol flavored e-cigarettes', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Usual Cigarettes; Receive Tobacco E-cigarettes', 'description': 'Participants can continue to smoke their usual cigarettes and receive tobacco flavored e-cigarettes', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheaded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Avoid Menthol Cigarettes; Menthol E-cigarettes', 'description': 'Participants avoided smoking menthol cigarettes and received menthol flavored e-cigarettes'}, {'id': 'OG001', 'title': 'Avoid Menthol Cigarettes; Tobacco E-cigarettes', 'description': 'Participants avoided smoking menthol cigarettes and received tobacco flavored e-cigarettes'}, {'id': 'OG002', 'title': 'Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes', 'description': 'Participants could continue to smoke their usual cigarettes and received menthol flavored e-cigarettes'}, {'id': 'OG003', 'title': 'Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes', 'description': 'Participants could continue to smoke their usual cigarettes and received tobacco flavored e-cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '6.0', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Estimated mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.72', 'estimateComment': 'Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes', 'groupDescription': 'Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Estimated mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.22', 'estimateComment': 'Baseline adjusted model estimated mean ratio in cigarettes smoked per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes', 'groupDescription': 'Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Number of cigarettes smoked per day as self-reported on tobacco diary', 'unitOfMeasure': 'model estimated cigarettes per day', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.'}, {'type': 'PRIMARY', 'title': 'Number of E-cigarette Puffs Used Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Avoid Menthol Cigarettes; Menthol E-cigarettes', 'description': 'Participants avoided smoking menthol cigarettes and received menthol flavored e-cigarettes'}, {'id': 'OG001', 'title': 'Avoid Menthol Cigarettes; Tobacco E-cigarettes', 'description': 'Participants avoided smoking menthol cigarettes and received tobacco flavored e-cigarettes'}, {'id': 'OG002', 'title': 'Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes', 'description': 'Participants could continue to smoke their usual cigarettes and received menthol flavored e-cigarettes'}, {'id': 'OG003', 'title': 'Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes', 'description': 'Participants could continue to smoke their usual cigarettes and received tobacco flavored e-cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '25.5', 'groupId': 'OG002'}, {'value': '14.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Estimated mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.03', 'ciLowerLimit': '1.39', 'ciUpperLimit': '6.61', 'estimateComment': 'Model estimated mean ratio in puffs of e-cigarettes used per day among those randomized to conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes', 'groupDescription': 'Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Estimated mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.92', 'estimateComment': 'Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes', 'groupDescription': 'Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Self-reported number of puffs of e-cigarettes used per day', 'unitOfMeasure': 'model estimated e-cig puffs per day', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs', 'description': 'Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes'}, {'id': 'FG001', 'title': 'Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs', 'description': 'Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes'}, {'id': 'FG002', 'title': 'Usual Cigs; Menthol E-cig Then Tobacco E-cigs', 'description': 'Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes'}, {'id': 'FG003', 'title': 'Usual Cigs; Tobacco E-cig Then Menthol E-cigs', 'description': 'Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Completed Week 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Participants included as having "started" the study are those who completed the baseline visit'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs', 'description': 'Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes'}, {'id': 'BG001', 'title': 'Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs', 'description': 'Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes'}, {'id': 'BG002', 'title': 'Usual Cigs; Menthol E-cig Then Tobacco E-cigs', 'description': 'Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes'}, {'id': 'BG003', 'title': 'Usual Cigs; Tobacco E-cig Then Menthol E-cigs', 'description': 'Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '11', 'groupId': 'BG000'}, {'value': '49', 'spread': '10', 'groupId': 'BG001'}, {'value': '48', 'spread': '8', 'groupId': 'BG002'}, {'value': '47', 'spread': '14', 'groupId': 'BG003'}, {'value': '47', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Those who completed the Baseline visit of the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-28', 'size': 657069, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-12-19T12:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2017-05-22', 'resultsFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-08', 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cigarettes Smoked Per Day', 'timeFrame': '1 month', 'description': 'Number of cigarettes smoked per day as self-reported on tobacco diary'}, {'measure': 'Number of E-cigarette Puffs Used Per Day', 'timeFrame': '1 month', 'description': 'Self-reported number of puffs of e-cigarettes used per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self identify as African American\n* smoke primarily menthol cigarettes\n* be between the ages of 18 and 64\n* smoke a minimum number of cigarettes per day\n* agree to abstain from menthol cigarettes for an 8 week period\n\nExclusion Criteria:\n\n* current unstable medical / psychiatric condition\n* regular use any form of nicotine or tobacco other than cigarettes\n* are pregnant or breast feeding\n\nThe investigators will evaluate if there are other reasons why someone may not be eligible to participate'}, 'identificationModule': {'nctId': 'NCT03164668', 'briefTitle': 'Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes', 'orgStudyIdInfo': {'id': '1609M94682'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual cigs; menthol e-cig then tobacco e-cigs', 'description': 'Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes', 'interventionNames': ['Other: menthol flavored e-cigarette', 'Other: tobacco flavored e-cigarette']}, {'type': 'OTHER', 'label': 'Usual cigs; tobacco e-cig then menthol e-cigs', 'description': 'Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes', 'interventionNames': ['Other: menthol flavored e-cigarette', 'Other: tobacco flavored e-cigarette']}, {'type': 'OTHER', 'label': 'avoid menthol cigs; menthol e-cig then tobacco e-cigs', 'description': 'Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes', 'interventionNames': ['Other: menthol flavored e-cigarette', 'Other: tobacco flavored e-cigarette']}, {'type': 'OTHER', 'label': 'avoid menthol cigs; tobacco e-cig then menthol e-cigs', 'description': 'Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes', 'interventionNames': ['Other: menthol flavored e-cigarette', 'Other: tobacco flavored e-cigarette']}], 'interventions': [{'name': 'menthol flavored e-cigarette', 'type': 'OTHER', 'description': 'menthol flavored e-cigarette', 'armGroupLabels': ['Usual cigs; menthol e-cig then tobacco e-cigs', 'Usual cigs; tobacco e-cig then menthol e-cigs', 'avoid menthol cigs; menthol e-cig then tobacco e-cigs', 'avoid menthol cigs; tobacco e-cig then menthol e-cigs']}, {'name': 'tobacco flavored e-cigarette', 'type': 'OTHER', 'description': 'tobacco flavored e-cigarette', 'armGroupLabels': ['Usual cigs; menthol e-cig then tobacco e-cigs', 'Usual cigs; tobacco e-cig then menthol e-cigs', 'avoid menthol cigs; menthol e-cig then tobacco e-cigs', 'avoid menthol cigs; tobacco e-cig then menthol e-cigs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical and Translational Sciences Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}