Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 8:49 AM
Study NCT ID:
NCT04646668
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Abuse Liability Among African American and White Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}}}}, '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': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'llambart@kumc.edu', 'phone': '9139457862', 'title': 'Leah Lambart Graduate Research Assistant', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'No differences in definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Cigarette', 'description': 'At the first visit, all participants used their usual brand of cigarette.\n\nParticipants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with cigarettes.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'E-Cigarette', 'description': 'At the second and third visits, participants were randomly assigned either e-cigarette or heat not burn. All participants completed a visit for each product but the order was random.\n\nParticipants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with the e-cigarette.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Heat Not Burn', 'description': 'At the second and third visits, participants were randomly assigned either e-cigarette or heat not burn. All participants completed a visit for each product but the order was random.\n\nParticipants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with heat-not-burn.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nicotine Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cigarette', 'description': 'Participants used their own brand cigarette during the first study visit.'}, {'id': 'OG001', 'title': 'E-Cigarette', 'description': 'Participants who used the e-cigarette product during either the second or third study visit.'}, {'id': 'OG002', 'title': 'Heat Not Burn', 'description': 'Participants who used the heat not burn product during either the second or third study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.13', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '35.6'}, {'value': '6.79', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '26.6'}, {'value': '9.15', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '22.5'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Due to the pilot nature of the current study, formal power calculations were not conducted.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 10 puff bout of product at 5 minutes', 'description': 'Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood plasma nicotine concentration 5 minutes after start'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cigarette, E-Cigarette Then Heat Not Burn.', 'description': 'At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.'}, {'id': 'FG001', 'title': 'Cigarette, Heat Not Burn Then E-Cigarette', 'description': 'At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cigarette, E-Cigarette Then Heat Not Burn.', 'description': 'At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.'}, {'id': 'BG001', 'title': 'Cigarette, Heat Not Burn Then E-Cigarette', 'description': 'At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.\n\nFollowing at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '65'}, {'value': '54.1', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '65'}, {'value': '54.1', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline blood plasma nicotine concentration'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-11', 'size': 490053, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-30T20:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '1. 20 eligible African American and white smokers will be randomized. A 1:1 randomization to product order (combustible cigarette, e-cigarette, heat-not-burn vs. combustible cigarette, heat-not-burn, e-cigarette). Randomization will be determined by computer-generated random numbers. Randomization assignments will be placed in sealed envelopes with sequential study identification numbers. After baseline data collection has been completed, the research assistant will select the sequential study identification number to determine the randomization assignment\n2. No blinding is involved.\n3. Due to the pilot nature of the current study, formal power calculations were not conducted. ANOVAs will be conducted to detect within-subject differences between products. A Bonferroni correction will be applied to adjust for multiple comparisons.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2020-11-09', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-26', 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nicotine Delivery', 'timeFrame': 'Baseline, after 10 puff bout of product at 5 minutes', 'description': 'Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '37042345', 'type': 'DERIVED', 'citation': 'Funk OL, Nollen NL, Wagener TL, Ahluwalia JS, Mayo MS, Mahmud KMF, Lambart L, Leavens ELS. Concurrent Choice Assessment of Preference and Substitutability of E-cigarettes and Heated Tobacco Products for Combustible Cigarettes Among African American and White Smokers. Nicotine Tob Res. 2023 Jul 14;25(8):1505-1508. doi: 10.1093/ntr/ntad052.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized crossover trial. Current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.', 'detailedDescription': "The study is a randomized crossover trial. Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). Throughout each visit, blood will be collected for nicotine analysis via an IV catheter placed in the patient's arm. Blood samples will be aliquoted into two separate vials. One will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. Puff topography will be collected passively throughout the session to measure puffing patterns. Participants will complete self-report measures of nicotine withdrawal and craving. Finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. At the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. Finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. We have no hypotheses related to the follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-Hispanic African American or white/Caucasian,\n* ≥21 years old, smoke 5-30 cigarettes per day,\n* daily cigarette smoker\n* smoked at current rate for at least 6 months\n* interested in trying e-cigarettes and heat not burn products\n* not interested in or unable/unwilling to quit cigarette smoking\n* willing to complete three in-person study visits\n* willing to have IV catheter placed\n\nExclusion Criteria:\n\n* Interested in quitting cigarettes in the next 30 days\n* use of smoking cessation pharmacotherapy in the past 30 days\n* use of non-cigarette tobacco products in the past 30 days\n* use of e-cigarettes \\>5x in lifetime\n* use of e-cigarettes ≥4 of the past 30 days\n* use of heat not burn products \\>5x in lifetime\n* use of heat not burn products ≥4 of the past 30 days\n* weight \\< 110 lbs\n* uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105)\n* pregnant, plans to become pregnant, or breastfeeding\n* live \\>10 miles from study site (Fairway CRU)\n* current enrollment is a research study or program that aims to alter tobacco use'}, 'identificationModule': {'nctId': 'NCT04646668', 'briefTitle': 'Comparative Abuse Liability Among African American and White Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Comparative Abuse Liability of Cigarettes, E-cigarettes, and Heat-not-burn Devices Among African American and White Smokers', 'orgStudyIdInfo': {'id': '00145421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'E-Cigarette then Heat not burn.', 'description': 'We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device.', 'interventionNames': ['Combination Product: E-cigarette and Heat not burn']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heat not burn then E-Cigarette', 'description': 'We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette.', 'interventionNames': ['Combination Product: E-cigarette and Heat not burn']}], 'interventions': [{'name': 'E-cigarette and Heat not burn', 'type': 'COMBINATION_PRODUCT', 'description': 'Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn).', 'armGroupLabels': ['E-Cigarette then Heat not burn.', 'Heat not burn then E-Cigarette']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Eleanor Leavens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}