Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for a Randomized, Controlled, Multicenter Study

JMIR Research Protocols
S Michael AnsariFrank Lüdicke

Abstract

Tobacco harm reduction, substituting less harmful tobacco products for combustible cigarettes, is a complementary approach for smokers who would otherwise continue to smoke. The Philip Morris International (PMI) Tobacco Heating System (THS) 2.2 is a novel tobacco product with the potential to reduce the risk of harm in smokers compared to continued smoking of combustible cigarettes. It heats tobacco electrically in a controlled manner, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from taking place and producing substantially lower levels of toxicants while providing nicotine, taste, ritual, and a sensory experience that closely parallels combustible cigarettes. Previous clinical studies have demonstrated reduced exposure to the toxicants (approaching the levels observed after quitting) for smokers who switched to THS 2.2, for three months. For adult smokers who would otherwise continue smoking combustible cigarettes, switching to THS 2.2 may represent an alternative way to reduce the risk of tobacco-related diseases. This study aimed to further substantiate the harm reduction potential of THS 2.2 by demonstrating favorable changes in a set of 8 coprimary endpoints, representative of ...Continue Reading

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Citations

Sep 18, 2020·BMJ : British Medical Journal·Anna B Gilmore, Sophie Braznell
Feb 16, 2019·Internal and Emergency Medicine·Julia HoengManuel C Peitsch
Jul 30, 2020·Vascular Medicine·Klaas Frederik FranzenDaniel Droemann
Jan 7, 2022·The Cochrane Database of Systematic Reviews·Harry Tattan-BirchJamie Brown

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Methods Mentioned

BETA
urine collection
urine sample collection
hormone replacement therapy

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NCT02503254
NCT02396381
NCT02649556
NCT02432729

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