Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

Study Overview
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Brief Summary
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This clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). In general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. Flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. Understanding how nicotine vaping products are used is important in assessing individual and population level health risks. Vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.

Detailed Description
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PRIMARY OBJECTIVE: I. Examine the influence of tobacco flavoring composition on vaping topography. II. Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography. SECONDARY OBJECTIVE: I. Examine the influence of tobacco flavoring composition on vaping topography. II. 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.

Official Title
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Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

Conditions
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Tobacco-Related Carcinoma

Intervention / Treatment
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* Other: Vaping
* Procedure: Biospecimen Collection
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current daily vapers of products containing nicotine 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 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: Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures 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 30 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaping -<br>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. | Other: Vaping<br>* Undergo vape puffing regimen<br>* Other names: Vape, Vaping;Procedure: Biospecimen Collection<br>* Undergo collection of saliva samples and oral cell samples<br>* Other names: Biological Sample Collection;Other: Questionnaire Administration<br>* Administer Quesitonnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puff Topography | Measure of vaping topography | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective questionnaires of product evaluation | Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point LIkert scale )not at all to extremely) | Up to 3 months |