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Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Sponsor: Ohio State University Comprehensive Cancer Center
Summary
This clinical trial studies how different ways of using oral nicotine pouches (ONPs) affect nicotine delivery, appeal, and side effects among adult cigarette smokers. ONPs are tobacco-free nicotine products that contain nicotine but no tobacco leaf and are used by placing them between the lip and gum. Because ONPs are not burned and do not contain tobacco leaf, they are being studied as a replacement for tobacco products to lower harmful effects, particularly among adult cigarette smokers. However, previous research on ONP use has often been done via controlled assessments which had users place them in one area of the mouth, which does not reflect how they are used in the real-world. Researchers believe this approach leaves gaps in knowledge on how nicotine is delivered, sensory effects, craving and withdrawal, appeal, and side effects. This trial will have participants use ONPs in different ways, such as placed between the upper lip and gum, placed between the lower lip and gum, and placing them however they would like. Researchers hope that by studying these different use patterns they will understand more about how they affect nicotine delivery, appeal, and side effects among adult cigarette smokers.
Official title: The Place Study: Exploring the Effects of Oral Nicotine Pouch Use Topography on Measured Abuse Liability and Adverse Effects
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2027-01-02
Completion Date
2028-12-31
Last Updated
2026-10-28
Healthy Volunteers
Yes
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Oral nicotine pouches
Complete at-home sampling of ONPs
Oral nicotine pouches
Use ONP with upper lip and gum placement
Oral nicotine pouches
Use ONP with lower lip and gum placement
Oral nicotine pouches
Use ONP with ad libitum use
Survey Administration
Ancillary studies
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States