Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-04 @ 11:46 AM
Study NCT ID:
NCT03635333
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of E-Cigarette Flavors on Adults TCORS 2.0
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D005421', 'term': 'Flavoring Agents'}], 'ancestors': [{'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'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'danielle.davis@yale.edu', 'phone': '2039747607', 'title': 'Danielle Davis', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Vanilla Low Nicotine Group (6mg/ml)', 'description': 'Participants who were assigned to the low nicotine condition and were exposed to vanilla flavor.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vanilla High Nicotine Group (18mg/ml)', 'description': 'Participants who were assigned to the high nicotine condition and were exposed to vanilla flavor.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cherry Low Nicotine Group (6mg/ml)', 'description': 'Participants who were assigned to the low nicotine condition and were exposed to cherry flavor.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 1, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cherry High Nicotine Group (18mg/ml)', 'description': 'Participants who were assigned to the high nicotine condition and were exposed to cherry flavor.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Tobacco Low Nicotine Group (6mg/ml)', 'description': 'Participants who were assigned to the low nicotine condition and were exposed to tobacco flavor.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 1, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Tobacco High Nicotine Group (18mg/ml)', 'description': 'Participants who were assigned to the high nicotine condition and were exposed to tobacco flavor.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Menthol Low Nicotine Group (6mg/ml)', 'description': 'Participants who were assigned to the low nicotine condition and were exposed to menthol flavor.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Menthol High Nicotine Group (18mg/ml)', 'description': 'Participants who were assigned to the high nicotine condition and were exposed to menthol flavor.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Randomized Non-Starter Low Nicotine Group (6mg/ml)', 'description': 'Participants who were randomized to the low nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Randomized Non-starter High Nicotine Group (18mg/ml)', 'description': 'Participants who were randomized to the high nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Other', 'notes': 'Participant stepped on nail between Lab 1 and Lab 2. Participant was treated with antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'notes': 'Participant reported minor throat irritation from e-cigarette', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change Score in Liking/Wanting of E-cigarette', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '53', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Nicotine, Tobacco', 'description': '6 mg nicotine combined with tobacco flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG001', 'title': 'Low Nicotine, Menthol', 'description': '6 mg nicotine combined with menthol flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG002', 'title': 'Low Nicotine,Cherry', 'description': '6 mg nicotine combined with cherry flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG003', 'title': 'High Nicotine, Tobacco', 'description': '18 mg nicotine combined with tobacco flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG004', 'title': 'High Nicotine, Menthol', 'description': '18 mg nicotine combined with menthol flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG005', 'title': 'High Nicotine, Cherry', 'description': '18 mg nicotine combined with cherry flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG006', 'title': 'Low Nicotine, Vanilla', 'description': '6 mg nicotine combined with vanilla flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}, {'id': 'OG007', 'title': 'High Nicotine, Vanilla', 'description': '18 mg nicotine combined with vanilla flavored e-juice\n\nNicotine: Nicotine level (6 or 18 mg)\n\nFlavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '-5.59', 'spread': '4.67', 'groupId': 'OG001'}, {'value': '-7.14', 'spread': '4.8', 'groupId': 'OG002'}, {'value': '-7.63', 'spread': '4.72', 'groupId': 'OG003'}, {'value': '8.41', 'spread': '4.73', 'groupId': 'OG004'}, {'value': '0.42', 'spread': '4.78', 'groupId': 'OG005'}, {'value': '4.77', 'spread': '4.65', 'groupId': 'OG006'}, {'value': '5.48', 'spread': '4.74', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (+10 minutes) to end of lab session (+40 minutes)', 'description': 'The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \\[range -100 to 100\\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The study started in May 2019 and the study was active between May 2019 and October 2020 and 9 participants were enrolled. However, due to study changes communicated previously, analyses only reflect enrolled participants who completed the study following the study protocol change (i.e., addition of a laboratory session in October 2020). Randomized non-starters were excluded from analyses (n=8, 5 low nicotine, 3 high nicotine). Those who completed at least one lab had data included in analyses'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Nicotine', 'description': '18 mg nicotine'}, {'id': 'FG001', 'title': 'Low Nicotine', 'description': '6mg/ml nicotine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Vanilla Flavor', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Cherry Flavor', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Menthol Flavor', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Tobacco Flavor', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Nicotine Group (6mg/ml)', 'description': 'Participants that were assigned to the low nicotine condition and exposed to tobacco, menthol, cherry, and vanilla.'}, {'id': 'BG001', 'title': 'High Nicotine Group (18mg/ml)', 'description': 'Participants that were assigned to the high nicotine condition and exposed to tobacco, menthol, cherry, and vanilla.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '35.9', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', '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': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants included in the primary analyses (those who were enrolled in the updated study design October 2020).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-12', 'size': 451571, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-05T13:54', 'hasProtocol': True}, {'date': '2023-04-12', 'size': 211322, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-13T15:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2018-08-13', 'resultsFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-16', 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Score in Liking/Wanting of E-cigarette', 'timeFrame': 'Baseline (+10 minutes) to end of lab session (+40 minutes)', 'description': 'The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \\[range -100 to 100\\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nicotine Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.', 'detailedDescription': 'This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.\n\nAs of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 21-34 years or 35 -50 years\n* Able to read and write\n* Smoking \\>/= 1 cigarettes or cigars/day\n* Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes\n* Not seeking treatment to stop smoking\n\nExclusion Criteria:\n\n* Daily use of other drugs including prescribed psychoactive drugs\n* Any significant current medical or psychiatric condition\n* Known hypersensitivity to propylene glycol\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT03635333', 'briefTitle': 'Effects of E-Cigarette Flavors on Adults TCORS 2.0', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effects of E-Cigarette Flavors on Adults', 'orgStudyIdInfo': {'id': '2000023077-2'}, 'secondaryIdInfos': [{'id': '2U54DA036151-06', 'link': 'https://reporter.nih.gov/quickSearch/2U54DA036151-06', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low nicotine, tobacco', 'description': '6 mg nicotine combined with tobacco flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'Low nicotine, menthol', 'description': '6 mg nicotine combined with menthol flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'Low nicotine,cherry', 'description': '6 mg nicotine combined with cherry flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'High nicotine, tobacco', 'description': '18 mg nicotine combined with tobacco flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'High nicotine, menthol', 'description': '18 mg nicotine combined with menthol flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'High Nicotine, cherry', 'description': '18 mg nicotine combined with cherry flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'Low Nicotine, Vanilla', 'description': '6 mg nicotine combined with vanilla flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}, {'type': 'EXPERIMENTAL', 'label': 'High Nicotine, Vanilla', 'description': '18 mg nicotine combined with vanilla flavored e-juice', 'interventionNames': ['Drug: Nicotine', 'Drug: Flavor']}], 'interventions': [{'name': 'Nicotine', 'type': 'DRUG', 'description': 'Nicotine level (6 or 18 mg)', 'armGroupLabels': ['High Nicotine, Vanilla', 'High Nicotine, cherry', 'High nicotine, menthol', 'High nicotine, tobacco', 'Low Nicotine, Vanilla', 'Low nicotine, menthol', 'Low nicotine, tobacco', 'Low nicotine,cherry']}, {'name': 'Flavor', 'type': 'DRUG', 'description': 'Flavor of e-juice (tobacco, menthol, cherry, vanilla)', 'armGroupLabels': ['High Nicotine, Vanilla', 'High Nicotine, cherry', 'High nicotine, menthol', 'High nicotine, tobacco', 'Low Nicotine, Vanilla', 'Low nicotine, menthol', 'Low nicotine, tobacco', 'Low nicotine,cherry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CMHC, Substance Abuse Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}