Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 23, 2022
Date Accepted: Aug 10, 2022
Biomarkers of exposure and potential harm in exclusive users of nicotine pouches and current, former and never smokers: A cross-sectional clinical study protocol
ABSTRACT
Background:
Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco/nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy.
Objective:
This two-centre, cross-sectional confinement study conducted in Denmark and Sweden aims to determine whether biomarkers of exposure to tobacco toxicants (BoE) and biomarkers of potential harm (BoPH) in exclusive users of NPs show favourable differences compared with current smokers.
Methods:
Participants will be healthy NP users (n=100), and current, former or never smokers (n=40 each), as confirmed by urinary cotinine and exhaled carbon monoxide. During a 24-hour confinement period, participants will be asked to use their usual product (NP or cigarette) as normal, and BoE/BoPH will be measured in blood and 24-hour urine samples and compliance determined using anabasine, anatabine and N-(2-cyanoethyl)valine. BoE/BoPH will be compared between NP users and current, former, and never smokers. Urinary total NNAL [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 carboxyhaemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein cholesterol (BoPH) will be evaluated as primary outcomes. Other measures include 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 are expected in mid-2022 and will be published 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 relative to smokers, and on the potential role of NPs in THR. Clinical Trial: The study has been registered on the International Standard Randomized Controlled Trial Number (ISRCTN) registry (ISRCTN16988167).
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