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Informing Oral Nicotine Pouch Regulations to Promote Public Health
Sponsor: Ohio State University Comprehensive Cancer Center
Summary
This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-01-13
Completion Date
2028-08-31
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert low FBN R/S ONP
Nicotine Oral Pouch
Insert low FBN \> 99% S ONP
Nicotine Oral Pouch
Insert high R/S ONP
Nicotine Oral Pouch
Insert high FBN \> 99% ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
Text Message-Based Navigation Intervention
Receive text with a link to daily diary surveys
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States