Grant Number:	1R01CA289551-01 Interpret this number
Primary Investigator:	Keller-Hamilton, Brittney
Organization:	Ohio State University
Project Title:	Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer Disparities in Appalachia
Fiscal Year:	2024

PROJECT ABSTRACT Rural Appalachian counties have the highest cancer incidence and mortality rates in the United States (US). While most cancer disparities are narrowing between Appalachian and non-Appalachian areas of the US, disparities in lung and oral cancers are widening. A high prevalence of cigarette smoking (i.e., >30% in many rural Appalachian counties vs. 11.5% nationally) primarily contributes to these disparities. As cultural factors, deficiencies in the rural Appalachian healthcare system, and tobacco industry actions have undermined the success of tobacco control approaches that proved successful elsewhere, we propose a new approach to reduce the prevalence of cigarette smoking in rural Appalachia. Oral nicotine pouches (ONPs, e.g., Zyn, On!), which contain nicotine but no tobacco, have a similar toxicant profile to medicinal nicotine replacement therapy (NRT), with most carcinogens and toxicants below the limit of detection. ONPs deliver nicotine similarly to NRT lozenges but are about half as expensive, are marketed to smokers, and our preliminary data indicate that rural Appalachian smokers find them more socially acceptable than cigarettes and more palatable than NRT. We propose a 6-month, two-arm, remote, randomized switching trial of 1,000 adult smokers who live in rural Appalachia. Participants will be randomized to either an ONP or an NRT (patch and lozenge) arm. During a 2- week Sampling Phase, participants will sample products in their relevant study arm in a range of flavors and nicotine concentrations and will select the flavor (ONP arm) and nicotine concentration (ONP and NRT arms) for use during the Switch Phase. During a 12-week Switch Phase, participants will attempt to stop smoking cigarettes and completely switch to their study ONP or NRT using study products provided for free. During a 14-week Observation Phase, participants will no longer receive study products but will be followed to evaluate longer-term switching outcomes. Participants will self-report smoking and study product use on online surveys, and changes in cigarette smoking will be confirmed using remote carbon monoxide assessment. This significant and innovative study will be the first to evaluate whether ONPs are suitable substitutes for cigarette smoking among rural Appalachian adults. If our study finds that ONP participants have greater success in reducing or quitting smoking than NRT participants, results will provide a foundation for interventions and regulations that support switching from cigarette smoking to ONP use. If our study finds that ONPs provide the same (or worse) effects on smoking outcomes as NRT, results will suggest that public health practitioners, regulators, and clinicians should steer smokers away from ONPs in favor of NRT.





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