Abstract
Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in health effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public health impact of THPs.Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760
Highlights
Cigarette smoking is a well-known cause of human disease [1]
For participants in arm B, at visit 1, they will be provided with the THP1.1 (RT) and stick consumables equivalent to no more than 150% of the self-reported number of cigarettes per day (CPD) consumed at screening, with the possibility of more, up to a total of 200% of original cigarette per day (CPD) consumption, before visit 2 by visiting the study site
At visits 2–12, product usage will be assessed by return of all empty, partused, and unused packs of Tobacco heating products (THPs) consumables, and the batch of product will be supplied at 120% of usage in the previous period, up to the limit of 200% of pre-screening consumption
Summary
Cigarette smoking is a well-known cause of human disease [1]. The associated risks are known to correlate with duration of smoking and daily cigarette consumption, and quitting reduces these risks [2, 3]. Health burden of tobacco use is a clear public health priority and has led to a series of regulatory and educational initiatives to persuade people not to smoke [1, 4]. Despite these efforts, smoking rates in adult populations worldwide remains at 10–40% in most countries [5], and the World Health Organization (WHO) forecasts that there will be around 1.5 billion tobacco smokers worldwide in 2050 [6]. The substitution of cigarette smoking for potentially reduced-risk nicotine delivery systems, could offer substantial public health gains if widely adopted [7, 8]. Tobacco researchers and policy experts have long embraced the idea that less harmful sources of nicotine could provide rewarding effects similar to that of cigarettes
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