a Randomized, Controlled Study to assess Changes in Biomarkers of Exposures among adults Who Smoke That Switch to Oral Nicotine Pouch Products Relative to Continuing Smoking or Stopping all Tobacco Use.

Introduction:
This article presents the results of a randomized, controlled study that assessed biomarkers of exposure (BoE) to select harmful and potentially harmful constituents in adults who smoke and switch to oral tobacco products (on!®mint nicotine pouches; test products) compared to continuing smoking cigarettes (CS) and completely quitting all tobacco use (NT). The study aimed to evaluate changes in BoE levels after 7 days of using the test products.

Key Points:

* The study enrolled healthy male and female adults who smoked at least 10 but no more than 30 combustible cigarettes per day for at least 12 months prior to screening.
* Participants were randomized into five groups: CS, 2 mg test product, 4 mg test product, 8 mg test product, and NT.
* The primary objective was to compare urinary total NNaL in adults who completely switched from smoking to using the test products with those who continued to smoke cigarettes for 7 days.
* Secondary objectives included the comparison of 19 additional biomarkers of exposure and product use behavior on Day 7.
* Participants in the test product groups used a mean of 10.8 ±7.7, 11.2 ±6.91, and 7.6±4.24 pouches per day for the 2, 4, and 8 mg products, respectively.
* Creatinine-adjusted urinary total NNaL was statistically significantly reduced in the test product groups compared to the CS group.
* Of the 19 secondary end point biomarkers of exposure, all except NEs were also statistically significantly reduced (P<.05) in the test product groups compared to the group that continued smoking.

Main Message:
The substantial reduction in harmful and potentially harmful constituent exposure suggests that complete switching from cigarettes to test products may present a harm reduction opportunity for adults who smoke. however, it is important to note that the test products contain nicotine, which is addictive, and the best option for adults who smoke is to quit using all tobacco products.

Rensch, J., Edmiston, J., Wang, J., Jin, X., & Sarkar, M. (2023). a Randomized, Controlled Study to assess Changes in Biomarkers of Exposures among adults Who Smoke That Switch to Oral Nicotine Pouch Products Relative to Continuing Smoking or Stopping all Tobacco Use. Journal of Clinical Pharmacology, 63(10), 1108–1118. https://doi.org/10.1002/jcph.2293