Informing Oral Nicotine Pouch Regulations to Promote Public Health
Ohio State University Comprehensive Cancer Center
160 participants
Jan 13, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Undergo blood sample and oral mucosa sample collection
Smoke usual brand cigarette
Insert low FBN R/S ONP
Insert low FBN \> 99% S ONP
Insert high R/S ONP
Insert high FBN \> 99% ONP
Insert ST
Ancillary studies
Receive text with a link to daily diary surveys
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06315881