Abstract
Background: This was a pre-market, observational, actual use study with the Tobacco Heating System (THS), a candidate modified risk tobacco product. The main goal of the study was to describe THS adoption within current adult daily smokers by replicating the usage of THS in real-world conditions with participants being able to consume cigarettes, THS, and any other nicotine-containing products (e.g., e-cigarettes, cigars, etc.) ad libitum. Methods: This study assessed self-reported stick-by-stick consumption of THS compared with the use of commercial cigarettes over six weeks. The aim of the analysis was to identify potential predictors for adoption of THS using stepwise logistic regression analysis. Results: By the end of the observational period (in Week 6), 14.6% of participants (n=965) had adopted THS meaning that THS formed 70% or more of their total tobacco consumption. The main predictors of adoption were the liking of the smell, taste, aftertaste, and ease of use of THS. The proportion of adoption was higher in participants aged 44 years and older and in Hispanic or Latino adult smokers. Additionally, adoption of THS was more likely in participants who had never attempted to quit smoking and in participants who smoked up to 10 cigarettes per day. Finally, the adoption of THS was higher in participants who consumed both regular and menthol THS compared with those who consumed only one THS variant. Conclusions: The findings suggest that the introduction of THS in the U.S. has the potential to result in adoption by current adult smokers who would otherwise continue to smoke cigarettes, and that the adoption of THS is unlikely to result in an increase of tobacco consumption. Post-marketing studies will provide further insights on THS adoption and THS use patterns to allow assessment of the impact of the THS at the individual and the overall population level.