Overview

Informing Oral Nicotine Pouch Regulations to Promote Public Health

Status:
RECRUITING
Trial end date:
2028-08-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Specimen Handling
Tobacco Products
Tobacco, Smokeless