Grant Number:	1R21CA309618-01 Interpret this number
Primary Investigator:	Dai, Hongying
Organization:	University Of Nebraska Medical Center
Project Title:	Population Assessment of Tobacco Use Transition and Health Effects Associated with Adult Nicotine Pouch Use
Fiscal Year:	2026

Project Summary Smoking is the leading cause of cancer and cancer deaths, causing at least 12 types of cancer with tobacco- related cancers and accounting for 40% of all cancer cases identified. In 2022, about 11.6% of U.S. adults, over 28 million people, smoked cigarettes some days or every day. Quitting smoking can greatly reduce the risk of disease and early death. Most smokers were motivated to quit and about half made past-year quit attempts, but only 7.5% achieved long-term cessation. Oral nicotine pouches entered the U.S. market in 2016 and sales increased by 641% from August-December 2019 to January-March 2022. Nicotine pouches are small and dissolvable microfiber sachets pre-filled with microcrystalline powder, nicotine, and other constituents. They typically contain high nicotine levels in nicotine salts and can be placed in the mouth between the lip and gum without spitting. Nicotine pouch use may be linked to nicotine dependence, mouth lesions, and nausea, but it avoids respiratory exposure and lacks certain tobacco toxicants present in cigarettes. Therefore, fully transitioning from combustible cigarettes to nicotine pouches could serve as a harm reduction strategy for smokers to lower cancer-related risks. However, empirical evidence on tobacco use transitions and health effects associated with adult nicotine pouch use in the U.S. population remains limited. Additionally, understanding factors that influence the nicotine pouch ↔ cigarette transitions and health outcomes can have important implications for elucidating cancer risk and related outcomes. This study will harmonize the nationally representative Population Assessment of Tobacco and Health (PATH) Study Waves 7-9 (2022-2025) Interview survey data and restricted biomarker data and examine the longitudinal effects of nicotine pouch use on tobacco use behaviors, BOEs, and nicotine dependence. In Aim 1, we will examine prospective within-subjects associations of nicotine pouch use, tobacco use transition, and related health effects (ie.., BOEs, carcinogen- related cancer risk, nicotine dependence) using weighted generalized equation estimation (GEE) models adjusted for demographics and other covariates. In Aim 2, we will use biomarkers, socio-demographics, tobacco use history, psychosocial profiles, and community characteristics to develop bio-socio-psycho risk scores in prediction of smoking cessation, relapse to combustible cigarette smoking, and health outcomes linked to nicotine pouch use using machine learning algorithms. This study is innovative in its integration of biospecimen and survey data to examine longitudinal nicotine pouch ↔ cigarette transitions and their associated health effects. It also employs machine learning algorithms to uncover complex relationships among numerous factors influencing nicotine pouch use and smoking transition behaviors. This study is significant because it provides timely evidence regarding nicotine pouch use and health outcomes, which can guide future regulatory decisions and clinical recommendations for nicotine pouch use as a smoking cessation aid, ultimately reducing tobacco- related cancer mortality and morbidity. 1





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