A study to investigate changes in the levels of biomarkers of exposure to selected cigarette smoke constituents in Japanese adult male smokers who switched to a non-combustion inhaler type of tobacco product

• Published in: Regulatory toxicology and pharmacology Vol. 71; no. 3; pp. 498 - 506
• Main Authors: Miura, Naoki, Yuki, Dai, Minami, Naoki, Kakehi, Aoi, Futamura, Yasuyuki
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.04.2015
• Subjects: Adult; Biomarkers; Biomarkers - blood; Biomarkers - urine; Blood Chemical Analysis; Cigarette; Clinical study; Exposure; Humans; Japan; Male; Middle Aged; Mutagenicity Tests; Mutagens - adverse effects; Risk Assessment; Smoke - adverse effects; Smokeless tobacco; Smoking; Smoking - adverse effects; Smoking - blood; Smoking - urine; Time Factors; Tobacco Products - adverse effects; Tobacco, Smokeless - adverse effects; Urinalysis; Young Adult; Japan; Cigarette; Biomarkers; Exposure; Smokeless tobacco; Smoking; Clinical study
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2015.02.007

•A non-combustion inhaler type of tobacco product (NCIT) was investigated.•Clinical study was conducted with 60 Japanese male smokers and 20 non-smokers.•Change in levels in 14 biomarker of exposure (BOE) were monitored for 4weeks.•Switching from cigarette to NCIT showed significant reduction in all BOEs measured.•BOEs in nonsmokers indicated the extent of the exposure from living environment. In a clinical study, changes in 14 biomarkers of exposures (BOEs) from 10 tobacco smoke constituents and mutagens detected by the urine mutagenicity test were investigated using a non-combustion inhaler type of tobacco product (NCIT) by switching from a conventional cigarette. This study was conducted in 80 Japanese healthy adult males with a 4-week residential, controlled, open-label, parallel group design. After randomization, 40 smokers used NCIT with approximately 750 aspirations, other 20 smokers smoked approximately 20 pieces of an assigned 1-mg ISO tar conventional cigarette (CC1) every day. Twenty non-smokers (NS) did not use any tobacco product. Under this study condition, switching from cigarette to NCIT showed significant reduction in all BOEs measured. On day 29, the levels of these BOEs were almost the same as those in the NS group, except BOEs of nicotine and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK). This suggested that the exposure to 8 constituents and mutagens in the NCIT group was similar to that in the NS group, while the exposure to nicotine was higher. Although the precise exposure level to NNK was not estimated because of the long half-life of its BOE, it would be substantially lower in the NCIT group than in the CC1 group.