Roswell Park Cancer Institute
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.
Tobacco-Related Carcinoma
Vaping
Biospecimen Collection
Questionnaire Administration
Not Applicable
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 72 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Prevention |
| Official Title : | Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography |
| Actual Study Start Date : | August 30, 2023 |
| Estimated Primary Completion Date : | August 30, 2026 |
| Estimated Study Completion Date : | August 30, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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. |
Other: Vaping Procedure: Biospecimen Collection Other: Questionnaire Administration |
| Ages Eligible for Study: | 21 Years to 55 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
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Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263