A randomized, controlled study to assess changes in biomarkers of exposures among adults who smoke who switch to oral nicotine pouch products relative to continuing smoking or stopping all tobacco use.

The purpose of this open-label, randomized, controlled, in-clinic, five parallel-group study was to assess biomarkers of exposure (BoEs) to select harmful and potentially harmful constituents (HPHCs) in adults who smoke (AS; N = 144 switching to oral tobacco products (on! mint nicotine pouches; Test Products) compared to continuing smoking cigarettes (CS) and completely quitting all tobacco products (NT). Changes in 20 BoEs to select HPHCs, including 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), were evaluated. AS smoked their usual brand cigarettes for 2 days (baseline assessments) and then were randomly assigned to ad libitum use of 2, 4, or 8mg Test Products, CS, or NT for 7 days. Analysis of covariance was used to assess the Day 7 BoE levels between each group using Test Products, CS, and NT. The creatinine adjusted total urinary NNAL and other 18 of 19 BoE levels, (except nicotine equivalents [NE]), were significantly lower (P<0.05) on Day 7, among all Test Product groups compared to CS. Geometric least square means (GLSM) were reduced for all BoEs, except NE, in Test Product groups by ∼42-96% compared to CS group and reductions were comparable to NT group. The GLSM for urinary NE between the Test Product and CS groups, although not significantly different, the Day 7 mean change relative to the CS group were; 49.9%, 65.8%, and 101% for the 2mg, 4mg, and 8mg Test Product groups, respectively. The substantial reduction in HPHC exposure suggests complete switching from cigarettes to Test Products may present a harm reduction opportunity for AS. This article is protected by copyright. All rights reserved.