Study of Oral Nicotine Pouches Compared to Cigarettes and Smokeless Tobacco to Support Public Health Regulations

What this Trial Is About

This research aims to evaluate oral nicotine pouches ONPs to see if they can be a comparable substitute to cigarettes or smokeless tobacco ST products. ONPs contain nicotine but no tobacco and are considered lower risk than combustible cigarettes by the Food and Drug Administration. The study will explore how different nicotine concentrations and forms affect satisfaction, appeal, and switching behavior from cigarettes or ST to ONPs, as well as examine changes in oral microbiome interactions related to switching. The study has two phases. In Phase I, participants are randomly assigned to use one of four ONP products or their usual brand of cigarette or ST, with varying nicotine concentrations and forms. They will insert the ONP or use their usual product during study visits with blood samples taken at multiple time points. Phase II includes a one-week washout period using usual products, a control week with daily diary surveys via text, and then randomization to one of four ONP types for four weeks with additional study visits and oral mucosa sample collection. Participants will attend several study visits over up to three months, using study products and providing blood and oral mucosa samples. They will report tobacco use daily through text surveys during the control week. Researchers will measure nicotine delivery, product liking, craving and withdrawal suppression, and rates of switching to ONPs. The study also includes purchase task assessments and safety monitoring throughout the participation period.

Informing Oral Nicotine Pouch Regulations to Promote Public Health