Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
Study NCT ID:
NCT03830892
Status:
TERMINATED
Last Update Posted:
2021-06-04
First Post:
2019-01-14
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D062789', 'term': 'Tobacco Products'}], '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': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abarnes3@vcu.edu', 'phone': '804-827-4361', 'title': 'Dr. Andrew J. Barnes', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.', 'description': 'Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.\n\nAll adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.', 'eventGroups': [{'id': 'EG000', 'title': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power\n\nOwn Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Worsening cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Unrelated hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Breakpoint of Drug Purchase Tasks (DPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power'}, {'id': 'OG001', 'title': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power\n\nOwn Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power'}], 'classes': [{'title': 'own brand e-cigarette', 'categories': [{'measurements': [{'value': '3.95', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': '30 watts, 30 mg/ml nicotine', 'categories': [{'measurements': [{'value': '3.29', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '4.43', 'spread': '3.74', 'groupId': 'OG001'}]}]}, {'title': '15 watts, 30 mg/ml nicotine', 'categories': [{'measurements': [{'value': '3.51', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '3.63', 'groupId': 'OG001'}]}]}, {'title': '30 watts, 10 mg/ml nicotine', 'categories': [{'measurements': [{'value': '3.37', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '3.77', 'groupId': 'OG001'}]}]}, {'title': '15 watts, 10 mg/ml nicotine', 'categories': [{'measurements': [{'value': '3.74', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '3.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 180 minutes', 'description': 'The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).', 'unitOfMeasure': 'US Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.'}, {'type': 'PRIMARY', 'title': 'Breakpoint of Multiple Choice Procedure (MCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power'}, {'id': 'OG001', 'title': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power\n\nOwn Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power'}], 'classes': [{'title': 'Own brand e-cigarette', 'categories': [{'measurements': [{'value': '3.05', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': '30 watts, 30 mg/ml nicotine', 'categories': [{'measurements': [{'value': '2.51', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': '15 watts, 30 mg/ml nicotine', 'categories': [{'measurements': [{'value': '2.56', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': '30 watts, 10 mg/ml nicotine', 'categories': [{'measurements': [{'value': '2.63', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': '15 watts, 10 mg/ml nicotine', 'categories': [{'measurements': [{'value': '2.35', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '2.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 180 minutes.', 'description': 'The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).', 'unitOfMeasure': 'US Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.'}, {'type': 'PRIMARY', 'title': 'Effort for Product Puffs With the Progressive Ratio Task (PRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power'}, {'id': 'OG001', 'title': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power\n\nOwn Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power'}], 'classes': [{'title': 'own brand e-cigarette', 'categories': [{'measurements': [{'value': '4.95', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': '30 watts, 30 mg/ml nicotine', 'categories': [{'measurements': [{'value': '4.74', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': '15 watts, 30 mg/ml nicotine', 'categories': [{'measurements': [{'value': '4.58', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '4.38', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': '30 watts, 10 mg/ml nicotine', 'categories': [{'measurements': [{'value': '5.58', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': '15 watts, 10 mg/ml nicotine', 'categories': [{'measurements': [{'value': '4.89', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '1.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 180 minutes.', 'description': 'The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).', 'unitOfMeasure': 'e-cigarette puffs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'First measure given, regardless of task order, 90 minutes into each session', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Heart Rate', 'timeFrame': 'Recorded throughout each 4 hour study session using automated software every 10 seconds.', 'description': 'Heart rate (measured in bpm)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Systolic Blood Pressure', 'timeFrame': 'Recorded throughout each 4 hour study session using automated software every 5 minutes.', 'description': 'Blood pressure (measured in mm)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Recorded throughout each 4 hour study session using automated software every 5 minutes.', 'description': 'and blood pressure (measured in hg)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power'}, {'id': 'FG001', 'title': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power\n\nOwn Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': '15 Watts, 10 mg Nicotine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': '15 Watts, 30 mg Nicotine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': '30 Watts, 10 mg Nicotine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': '30 Watts, 30 mg Nicotine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Own Brand', 'comment': 'Exclusive e-cigarette users only used e-cigarettes during own brand session, dual users used either their cigarettes and e-cigarettes. Completion of either one considered a milestone depending on study arm', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study terminated due to COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Each participant will participate in 6 sessions. Sessions differ by the tobacco product used (see study arms). The sessions are ordered by latin-square; however, session order was NOT expected to change any outcomes and order effects are not relevant to the study. Therefore all outcome data was merged and analyzed only by arm and session without regard to order.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power'}, {'id': 'BG001', 'title': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette\n\nE-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nE-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power\n\nOwn Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power\n\nOwn Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.53', 'spread': '7.53', 'groupId': 'BG000'}, {'value': '29', 'spread': '6.84', 'groupId': 'BG001'}, {'value': '28.13', 'spread': '7.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', '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/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Middle Eastern', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants due to the protocol changes.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-16', 'size': 1325291, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-16T13:44', 'hasProtocol': True}, {'date': '2020-01-21', 'size': 99535, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-16T13:44', 'hasProtocol': False}, {'date': '2020-01-21', 'size': 184624, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-12-03T14:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session."}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes.\n\nAll participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette.\n\nThe first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Study terminated due to COVID', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2019-01-14', 'resultsFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-10', 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'First measure given, regardless of task order, 90 minutes into each session', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.'}, {'measure': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.'}, {'measure': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.'}, {'measure': 'Subjective Measures of Nicotine Abstinence Symptoms', 'timeFrame': 'Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).', 'description': 'Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Recorded throughout each 4 hour study session using automated software every 10 seconds.', 'description': 'Heart rate (measured in bpm)'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Recorded throughout each 4 hour study session using automated software every 5 minutes.', 'description': 'Blood pressure (measured in mm)'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Recorded throughout each 4 hour study session using automated software every 5 minutes.', 'description': 'and blood pressure (measured in hg)'}], 'primaryOutcomes': [{'measure': 'Breakpoint of Drug Purchase Tasks (DPT)', 'timeFrame': 'Up to 180 minutes', 'description': 'The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).'}, {'measure': 'Breakpoint of Multiple Choice Procedure (MCP)', 'timeFrame': 'Up to 180 minutes.', 'description': 'The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).'}, {'measure': 'Effort for Product Puffs With the Progressive Ratio Task (PRT)', 'timeFrame': 'Up to 180 minutes.', 'description': 'The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electronic Cigarettes']}, 'referencesModule': {'references': [{'pmid': '36480388', 'type': 'DERIVED', 'citation': 'White AM, Bono RS, Lester RC, Underwood M, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. The electronic nicotine delivery system (ENDS) purchase task: Are results sensitive to price framing? Exp Clin Psychopharmacol. 2023 Oct;31(5):895-901. doi: 10.1037/pha0000631. Epub 2022 Dec 8.'}, {'pmid': '34647773', 'type': 'DERIVED', 'citation': 'Hoetger C, Bono RS, White AM, Barnes AJ, Cobb CO. The interaction of nicotine concentration and device power on electronic nicotine delivery system (ENDS) abuse liability among exclusive ENDS users and dual users of ENDS and combustible cigarettes. Exp Clin Psychopharmacol. 2022 Dec;30(6):973-982. doi: 10.1037/pha0000523. Epub 2021 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy (determined by self-report)\n* between the ages of 21-55\n* willing to provide informed consent\n* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol\n\nExclusion Criteria:\n\n* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.\n\nSome study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.'}, 'identificationModule': {'nctId': 'NCT03830892', 'briefTitle': 'Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers', 'orgStudyIdInfo': {'id': 'HM20012696'}, 'secondaryIdInfos': [{'id': '2U54DA036105', 'link': 'https://reporter.nih.gov/quickSearch/2U54DA036105', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'E-cigarette User (Exclusive)', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette', 'interventionNames': ['Other: E-cigarette Lab Session 15 watts, 10 mg nicotine', 'Other: E-cigarette Lab Session 15 watts, 30 mg nicotine', 'Other: E-cigarette Lab Session 30 watts, 10 mg nicotine', 'Other: E-cigarette Lab Session 30 watts, 30 mg nicotine', 'Other: Own Brand Session - E-cigarette']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual User', 'description': 'Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette', 'interventionNames': ['Other: E-cigarette Lab Session 15 watts, 10 mg nicotine', 'Other: E-cigarette Lab Session 15 watts, 30 mg nicotine', 'Other: E-cigarette Lab Session 30 watts, 10 mg nicotine', 'Other: E-cigarette Lab Session 30 watts, 30 mg nicotine', 'Other: Own Brand Session - E-cigarette', 'Other: Own Brand Session - E-cigarette/Cigarette']}], 'interventions': [{'name': 'E-cigarette Lab Session 15 watts, 10 mg nicotine', 'type': 'OTHER', 'description': 'E-cigarette paired with low nicotine, low device power', 'armGroupLabels': ['Dual User', 'E-cigarette User (Exclusive)']}, {'name': 'E-cigarette Lab Session 15 watts, 30 mg nicotine', 'type': 'OTHER', 'description': 'E-cigarette paired with low nicotine, low device power', 'armGroupLabels': ['Dual User', 'E-cigarette User (Exclusive)']}, {'name': 'E-cigarette Lab Session 30 watts, 10 mg nicotine', 'type': 'OTHER', 'description': 'E-cigarette paired with low nicotine, low device power', 'armGroupLabels': ['Dual User', 'E-cigarette User (Exclusive)']}, {'name': 'E-cigarette Lab Session 30 watts, 30 mg nicotine', 'type': 'OTHER', 'description': 'E-cigarette paired with low nicotine, low device power', 'armGroupLabels': ['Dual User', 'E-cigarette User (Exclusive)']}, {'name': 'Own Brand Session - E-cigarette', 'type': 'OTHER', 'description': 'E-cigarette paired with own brand liquid and preferred power', 'armGroupLabels': ['Dual User', 'E-cigarette User (Exclusive)']}, {'name': 'Own Brand Session - E-cigarette/Cigarette', 'type': 'OTHER', 'description': 'Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power', 'armGroupLabels': ['Dual User']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23220', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Center for the Study of Tobacco Products', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Caroline Cobb (Amey), PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}, {'name': 'Andrew Barnes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}