• Christelle Haziza, Guillaume de La Bourdonnaye, Andrea Donelli, Valerie Poux, Dimitra Skiada, Rolf Weitkunat, Gizelle Baker, Patrick Picavet, and Frank Lüdicke.
• PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.
• Nicotine Tob. Res. 2020 Apr 17; 22 (4): 539-548.

IntroductionThe Tobacco Heating System (THS) is a "heat-not-burn" tobacco product designed to generate significantly lower levels of harmful and potentially harmful constituents (HPHCs) and present lower risk of harm than cigarettes. This study assessed the exposure reduction to selected HPHCs in smokers switching to menthol Tobacco Heating System (mTHS) 2.2 compared with smokers continuing smoking menthol cigarettes (mCCs) and smoking abstinence (SA) for 5 days in a confined setting, followed by an 86-day ambulatory period.MethodsA total of 160 healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Biomarkers of exposure to 16 HPHCs were measured in blood and 24-hour urine. Safety was monitored throughout the study. Information was also gathered on product evaluation, product use, subjective effects, and clinical risk markers (co-publication Part 2).ResultsNicotine uptake was comparable in both exposure groups (mTHS:mCC ratio of 96% on day 90). On day 5, biomarker of exposure levels to other HPHCs were reduced by 51%-96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers of exposure over ambulatory period. After 90 days of use, the level of satisfaction with mTHS and suppression of urge to smoke were comparable to mCC.ConclusionSwitching from mCCs to mTHS significantly reduced the exposure to HPHCs to levels approaching those observed in subjects who abstained from smoking for the duration of the study.ImplicationsThis study compared the impact of switching to mTHS on biomarkers of exposure, relative to continued smoking or SA.Clinical SignificanceTrial RegistrationNCT01989156 (ClinicalTrials.gov).© The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.

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