Informing Oral Nicotine Pouch Regulations to Promote Public Health

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.

NCT Number	NCT06315881
Lead Sponsor	Ohio State University Comprehensive Cancer Center Collaborators: National Cancer Institute (NCI)
Conditions	Tobacco-Related Carcinoma
Enrollment	160 participants
Start Date	2025-01-13
Primary Completion	2028-01-31 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-27