Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
NCT ID: NCT05876091
Last Updated: 2025-12-22
Study Results
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View full resultsBasic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2023-08-30
2024-10-29
Brief Summary
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Detailed Description
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* Examine the influence of tobacco flavoring composition on vaping topography.
* Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.
SECONDARY OBJECTIVE:
* Examine the influence of tobacco flavoring composition on vaping topography.
* Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.
OUTLINE:
The order of directed and ad libitum bouts are randomized within participants at each session.
SESSION 1: Participants puff their own brand liquid on study.
SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.
SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.
Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Vaping -
Description The order of directed and ad libitum bouts are randomized within participants at each session.
SESSION 1: Participants puff their own brand liquid on study.
SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.
SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.
Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.
Vaping
Undergo vape puffing regimen
Biospecimen Collection
Undergo collection of saliva samples and oral cell samples
Questionnaire Administration
Administer Quesitonnaire
Interventions
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Vaping
Undergo vape puffing regimen
Biospecimen Collection
Undergo collection of saliva samples and oral cell samples
Questionnaire Administration
Administer Quesitonnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No daily concurrent use of other tobacco products
* Self-reported general good health
* Women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
* Ability to speak, read, and write in English
* Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
* Self-reported taste or smell deficits
* Pregnant or nursing female participants
* Medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
* Unwilling to use open system vaping device in laboratory setting
* Positive diagnosis of human coronavirus 2019 infection (COVID-19) within 10 days prior to start of study intervention
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study intervention
21 Years
55 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Richard O'Connor
Role: PRINCIPAL_INVESTIGATOR
Roswell Park
Locations
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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I 3234822
Identifier Type: -
Identifier Source: org_study_id