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Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study

BACKGROUND: Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy. OBJECTIVE: T...

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Autores principales: Azzopardi, David, Haswell, Linsey Ellen, Frosina, Justin, McEwan, Michael, Gale, Nathan, Thissen, Jesse, Meichanetzidis, Filimon, Hardie, George
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9585440/
https://www.ncbi.nlm.nih.gov/pubmed/36201395
http://dx.doi.org/10.2196/39785
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author Azzopardi, David
Haswell, Linsey Ellen
Frosina, Justin
McEwan, Michael
Gale, Nathan
Thissen, Jesse
Meichanetzidis, Filimon
Hardie, George
author_facet Azzopardi, David
Haswell, Linsey Ellen
Frosina, Justin
McEwan, Michael
Gale, Nathan
Thissen, Jesse
Meichanetzidis, Filimon
Hardie, George
author_sort Azzopardi, David
collection PubMed
description BACKGROUND: Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy. OBJECTIVE: This 2-center, cross-sectional confinement study conducted in Denmark and Sweden aimed to determine whether biomarkers of exposure (BoEs) to tobacco toxicants and biomarkers of potential harm (BoPHs) in exclusive users of NPs show favorable differences compared with current smokers. METHODS: Participants were healthy NP users (target n=100) and current, former, or never smokers (target n=40 each), as confirmed by urinary cotinine and exhaled carbon monoxide concentrations. During a 24-hour confinement period, participants were asked to use their usual product (NP or cigarette) as normal, and BoEs and BoPHs were measured in blood and 24-hour urine samples, with compliance determined using anabasine, anatabine, and N-(2-cyanoethyl)valine. BoEs and BoPHs were compared between NP users and current, former, and never smokers. Urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (BoE to nicotine-derived nitrosamine ketone) and urinary 8-epi-prostaglandin F2α type III, exhaled nitric oxide, blood carboxyhemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein cholesterol (BoPHs) were evaluated as primary outcomes. Other measures included urinary 11-dehydrothromboxane B2, forced expiratory volume, carotid intima-media thickness, self-reported quality of life, and oral health. RESULTS: The results of this study were received in mid-2022 and will be published in late 2022 to early 2023. CONCLUSIONS: The results of this study will provide information on toxicant exposure and biomarkers associated with the development of smoking-related diseases among users of NPs compared with smokers, as well as on the potential role of NPs in THR. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN16988167; https://www.isrctn.com/ISRCTN16988167 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39785
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spelling pubmed-95854402022-10-22 Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study Azzopardi, David Haswell, Linsey Ellen Frosina, Justin McEwan, Michael Gale, Nathan Thissen, Jesse Meichanetzidis, Filimon Hardie, George JMIR Res Protoc Protocol BACKGROUND: Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy. OBJECTIVE: This 2-center, cross-sectional confinement study conducted in Denmark and Sweden aimed to determine whether biomarkers of exposure (BoEs) to tobacco toxicants and biomarkers of potential harm (BoPHs) in exclusive users of NPs show favorable differences compared with current smokers. METHODS: Participants were healthy NP users (target n=100) and current, former, or never smokers (target n=40 each), as confirmed by urinary cotinine and exhaled carbon monoxide concentrations. During a 24-hour confinement period, participants were asked to use their usual product (NP or cigarette) as normal, and BoEs and BoPHs were measured in blood and 24-hour urine samples, with compliance determined using anabasine, anatabine, and N-(2-cyanoethyl)valine. BoEs and BoPHs were compared between NP users and current, former, and never smokers. Urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (BoE to nicotine-derived nitrosamine ketone) and urinary 8-epi-prostaglandin F2α type III, exhaled nitric oxide, blood carboxyhemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein cholesterol (BoPHs) were evaluated as primary outcomes. Other measures included urinary 11-dehydrothromboxane B2, forced expiratory volume, carotid intima-media thickness, self-reported quality of life, and oral health. RESULTS: The results of this study were received in mid-2022 and will be published in late 2022 to early 2023. CONCLUSIONS: The results of this study will provide information on toxicant exposure and biomarkers associated with the development of smoking-related diseases among users of NPs compared with smokers, as well as on the potential role of NPs in THR. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN16988167; https://www.isrctn.com/ISRCTN16988167 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39785 JMIR Publications 2022-10-06 /pmc/articles/PMC9585440/ /pubmed/36201395 http://dx.doi.org/10.2196/39785 Text en ©David Azzopardi, Linsey Ellen Haswell, Justin Frosina, Michael McEwan, Nathan Gale, Jesse Thissen, Filimon Meichanetzidis, George Hardie. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.10.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Azzopardi, David
Haswell, Linsey Ellen
Frosina, Justin
McEwan, Michael
Gale, Nathan
Thissen, Jesse
Meichanetzidis, Filimon
Hardie, George
Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study
title Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study
title_full Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study
title_fullStr Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study
title_full_unstemmed Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study
title_short Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study
title_sort biomarkers of exposure and potential harm in exclusive users of nicotine pouches and current, former, and never smokers: protocol for a cross-sectional clinical study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9585440/
https://www.ncbi.nlm.nih.gov/pubmed/36201395
http://dx.doi.org/10.2196/39785
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