Informing Oral Nicotine Pouch Regulations to Promote Public Health
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.
Description
PRIMARY OBJECTIVES: I. Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST. II. Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs. EXPLORATORY OBJECTIVE: I. Examine changes in oral microbiome-host interactions associated with degree of switching from cigarettes/ST to ONPs. OUTLINE: PHASE I: Participants are randomized to use one of the 4 study ONP products or their usual product brand of ST or cigarette in either the low or high nicotine concentration…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Read and speak English * At least 21 years old * Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits * Willing to attend all study visits and use study ONPs * Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use) * Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant * Exhaled carbon monoxide (CO) reading \< 10 (Ph…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample and oral mucosa sample collection
- DrugCigarette
Smoke usual brand cigarette
- DrugNicotine Oral Pouch
Insert low FBN R/S ONP
- DrugNicotine Oral Pouch
Insert low FBN \> 99% S ONP
- DrugNicotine Oral Pouch
Insert high R/S ONP
- DrugNicotine Oral Pouch
Insert high FBN \> 99% ONP
- DrugSmokeless Tobacco
Insert ST
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio