Dynamic patterns of oral nicotine pouch use and transitions in cigarette and smokeless tobacco use: a fine-grained naturalistic cohort study - Abstract: The tobacco product landscape continues to evolve, now shifting to oral nicotine pouches (ONPs), which may represent a viable form of risk reduction. The prevalence of ONP use is currently low but all evidence indicates rates will escalate in a near-exponential fashion, as we are now in the early stages of another disruptive product shift. ONPs appear less harmful than cigarettes or traditional smokeless tobacco and have the potential to facilitate cessation among adults who use either product. However, it is equally apparent that many who use ONPs have never smoked or used smokeless tobacco and are at risk for initiation. Sizable proportions of adults who use ONPs are current, former, and never users of conventional tobacco and are at risk for onset of-, relapse to-, or maintenance of smoked or smokeless tobacco use, representing substantial and increased harm at both the individual and population level. Remarkably, the literature on ONP trajectories is scarce. Beyond questions of whether ONP use status enables tobacco cessation or increases risk for initiation, the current proposal is squarely focused on how these transitions unfold. Indeed, ONPs likely hold the potential to promote or reduce tobacco-related harm. The critical difference between these two outcomes lies in how they are used and their dynamic relationship to smoked and smokeless tobacco - two products responsible for >30% of US cancer deaths - underscoring the need to understand day-to-day patterns and trajectories of ONP use. Building upon our foundation of naturalistic research, including an ongoing cohort study of dual and mono-use of e-cigarettes and cigarettes, we propose a strategically aligned cohort study of adults who use ONPs (N=804). We focus on: 1) adults who Co-use ONPs and Conventional Tobacco (n=402, divided evenly between ONP/cigarette smokers and ONP/smokeless tobacco users) and 2) adults who Exclusively Use ONPs (n=402, divided evenly between ONP/former smokers, ONP/former smokeless users, and ONP/never smoker or smokeless users), all tracked through a combination of a) detailed daily diaries over 3 months, b) serial bursts of daily diaries that coincide with c) episodic monthly surveys over a 1-year follow-up, and d) biological verification of abstinence. Beyond our initial aim to describe granular use patterns, our principal focus is to identify ONP patterns that lead to transitions into and out of cigarette and smokeless tobacco use. Thus, we offer the ability to characterize ONP use in ways not yet addressed in the literature and to understand how these patterns relate to risk reducing vs promoting transitions in tobacco use. As an added strength, we have the unique ability to pool data across our ongoing and proposed cohort studies, offering unparalleled comparisons of use patterns across eight cohorts (combinations of ONP, cigarette, smokeless tobacco, and e-cigarette use), all tracked congruently to allow for data integration. The resulting dataset(s) will be made publicly available, providing what we believe is the most in-depth understanding of tobacco use patterns. Ultimately, and regardless of outcome, results will inform decision making that enable or impede the proliferation of ONPs, the fastest growing nicotine product in the US marketplace.
