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Background - In recent years there has been a proliferation of alternative tobacco and nicotine products that reduce consumers’ exposure to harmful substances and therefore have the potential to reduce risk to health. Post-market surveillance enables the evaluation of newly introduced tobacco and nicotine products (aka potentially reduced risk products (PRRPs)) at a population level. This study aims to investigate tobacco and nicotine consumer demographics and discover how people are using these products, and characterise behavioral trends as transitions between tobacco heated products (THPs) and other nicotine products. These behavioural aspects, in conjunction with the intrinsic risk of the product, are essential for assessing the potential health effects and establishing a population risk assessment. Design and methods - This epidemiological cross-sectional study will collect data using a self-administered study instrument from the general Japanese population aged 20 years and older. The targeted sampling size is up to 5,000 participants per study wave. The study addresses the following objectives: estimation of tobacco and nicotine use prevalence; characterisation of  product usage by product type; changes in use behaviour in general, with particular emphasis on the introduction of THPs in the time period of one year; risk perceptions of different tobacco products and no tobacco usage; and participant perceived health status and quality of life. Discussion - The description of tobacco and nicotine product use behaviour, the estimation of prevalence data, the measuring of product-specific risk perception and the change of tobacco use behaviour within one year will allow for a comprehensive assessment of the effect of introducing THPs into a market. These data could also be used to inform a system dynamics population model in order to estimate the public health impact of introducing a THP into the Japanese market.

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Protocol for a Japanese nationwide repeated cross-sectional study to assess tobacco and nicotine product use behaviour after market introduction of tobacco heating products (THPs)