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Biomarkers of Exposure and Potential Harm in Exclusive Users of Electronic Cigarettes and Current, Former and Never-Smokers: A Cross-Sectional Study Protocol

Received: 3 May 2022    Accepted: 19 May 2022    Published: 26 May 2022
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Abstract

Despite public health efforts to reduce the health burden of cigarettes by encouraging smoking cessation, a proportion of smokers remain unwilling to quit. A shift from smoking cessation to tobacco harm reduction, based on smokers switching completely to potentially less harmful products such as electronic cigarettes (ECs), has been proposed as an alternative strategy. This is a single-centre, cross-sectional confinement study, involving healthy exclusive Vuse EC users and current, former, or never-smokers. Exclusive EC use and smoking status will be confirmed by urinary cotinine and exhaled carbon monoxide levels. Participants will be confined for 24 hours, during which they will use their usual product (EC or cigarette) as normal. Biomarkers of exposure and potential harm will be analysed in 24-hour urine and blood and compliance will be measured using N-(2-cyanoethyl)valine. The primary objective is to quantitatively assess differences between EC users and current smokers in urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 8-epi-prostaglandin F Type III, exhaled nitric oxide, and carboxyhaemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein. Secondary objectives are to quantitatively assess differences between EC users and current smokers in selected urinary biomarkers of tobacco exposure, 11-dehydrothromboxane B2, forced expiratory volume in 1 second as a percentage of predicted, carotid intima-media thickness and a quality of life questionnaire. Endpoints will also be compared between EC users and former and never-smokers. The results of this study are anticipated to add to the current knowledge about the role of ECs in tobacco harm reduction.

Published in Journal of Health and Environmental Research (Volume 8, Issue 2)
DOI 10.11648/j.jher.20220802.17
Page(s) 116-127
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Biomarkers of Exposures, Biomarkers of Potential Harm, Electronic Cigarettes, Tobacco Harm Reduction

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    Nathan Gale, Linsey Ellen Haswell, Michael McEwan, David Azzopardi, Jesse Thissen, et al. (2022). Biomarkers of Exposure and Potential Harm in Exclusive Users of Electronic Cigarettes and Current, Former and Never-Smokers: A Cross-Sectional Study Protocol. Journal of Health and Environmental Research, 8(2), 116-127. https://doi.org/10.11648/j.jher.20220802.17

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    Nathan Gale; Linsey Ellen Haswell; Michael McEwan; David Azzopardi; Jesse Thissen, et al. Biomarkers of Exposure and Potential Harm in Exclusive Users of Electronic Cigarettes and Current, Former and Never-Smokers: A Cross-Sectional Study Protocol. J. Health Environ. Res. 2022, 8(2), 116-127. doi: 10.11648/j.jher.20220802.17

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    AMA Style

    Nathan Gale, Linsey Ellen Haswell, Michael McEwan, David Azzopardi, Jesse Thissen, et al. Biomarkers of Exposure and Potential Harm in Exclusive Users of Electronic Cigarettes and Current, Former and Never-Smokers: A Cross-Sectional Study Protocol. J Health Environ Res. 2022;8(2):116-127. doi: 10.11648/j.jher.20220802.17

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  • @article{10.11648/j.jher.20220802.17,
      author = {Nathan Gale and Linsey Ellen Haswell and Michael McEwan and David Azzopardi and Jesse Thissen and George Hardie},
      title = {Biomarkers of Exposure and Potential Harm in Exclusive Users of Electronic Cigarettes and Current, Former and Never-Smokers: A Cross-Sectional Study Protocol},
      journal = {Journal of Health and Environmental Research},
      volume = {8},
      number = {2},
      pages = {116-127},
      doi = {10.11648/j.jher.20220802.17},
      url = {https://doi.org/10.11648/j.jher.20220802.17},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jher.20220802.17},
      abstract = {Despite public health efforts to reduce the health burden of cigarettes by encouraging smoking cessation, a proportion of smokers remain unwilling to quit. A shift from smoking cessation to tobacco harm reduction, based on smokers switching completely to potentially less harmful products such as electronic cigarettes (ECs), has been proposed as an alternative strategy. This is a single-centre, cross-sectional confinement study, involving healthy exclusive Vuse EC users and current, former, or never-smokers. Exclusive EC use and smoking status will be confirmed by urinary cotinine and exhaled carbon monoxide levels. Participants will be confined for 24 hours, during which they will use their usual product (EC or cigarette) as normal. Biomarkers of exposure and potential harm will be analysed in 24-hour urine and blood and compliance will be measured using N-(2-cyanoethyl)valine. The primary objective is to quantitatively assess differences between EC users and current smokers in urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 8-epi-prostaglandin F2α Type III, exhaled nitric oxide, and carboxyhaemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein. Secondary objectives are to quantitatively assess differences between EC users and current smokers in selected urinary biomarkers of tobacco exposure, 11-dehydrothromboxane B2, forced expiratory volume in 1 second as a percentage of predicted, carotid intima-media thickness and a quality of life questionnaire. Endpoints will also be compared between EC users and former and never-smokers. The results of this study are anticipated to add to the current knowledge about the role of ECs in tobacco harm reduction.},
     year = {2022}
    }
    

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  • TY  - JOUR
    T1  - Biomarkers of Exposure and Potential Harm in Exclusive Users of Electronic Cigarettes and Current, Former and Never-Smokers: A Cross-Sectional Study Protocol
    AU  - Nathan Gale
    AU  - Linsey Ellen Haswell
    AU  - Michael McEwan
    AU  - David Azzopardi
    AU  - Jesse Thissen
    AU  - George Hardie
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    DO  - 10.11648/j.jher.20220802.17
    T2  - Journal of Health and Environmental Research
    JF  - Journal of Health and Environmental Research
    JO  - Journal of Health and Environmental Research
    SP  - 116
    EP  - 127
    PB  - Science Publishing Group
    SN  - 2472-3592
    UR  - https://doi.org/10.11648/j.jher.20220802.17
    AB  - Despite public health efforts to reduce the health burden of cigarettes by encouraging smoking cessation, a proportion of smokers remain unwilling to quit. A shift from smoking cessation to tobacco harm reduction, based on smokers switching completely to potentially less harmful products such as electronic cigarettes (ECs), has been proposed as an alternative strategy. This is a single-centre, cross-sectional confinement study, involving healthy exclusive Vuse EC users and current, former, or never-smokers. Exclusive EC use and smoking status will be confirmed by urinary cotinine and exhaled carbon monoxide levels. Participants will be confined for 24 hours, during which they will use their usual product (EC or cigarette) as normal. Biomarkers of exposure and potential harm will be analysed in 24-hour urine and blood and compliance will be measured using N-(2-cyanoethyl)valine. The primary objective is to quantitatively assess differences between EC users and current smokers in urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 8-epi-prostaglandin F2α Type III, exhaled nitric oxide, and carboxyhaemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein. Secondary objectives are to quantitatively assess differences between EC users and current smokers in selected urinary biomarkers of tobacco exposure, 11-dehydrothromboxane B2, forced expiratory volume in 1 second as a percentage of predicted, carotid intima-media thickness and a quality of life questionnaire. Endpoints will also be compared between EC users and former and never-smokers. The results of this study are anticipated to add to the current knowledge about the role of ECs in tobacco harm reduction.
    VL  - 8
    IS  - 2
    ER  - 

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Author Information
  • R&D Centre, British American Tobacco (Investments) Limited, Southampton, United Kingdom

  • R&D Centre, British American Tobacco (Investments) Limited, Southampton, United Kingdom

  • R&D Centre, British American Tobacco (Investments) Limited, Southampton, United Kingdom

  • R&D Centre, British American Tobacco (Investments) Limited, Southampton, United Kingdom

  • R&D Centre, British American Tobacco (Investments) Limited, Southampton, United Kingdom

  • R&D Centre, British American Tobacco (Investments) Limited, Southampton, United Kingdom

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