Use Behaviour and Pharmacokinetic Studies

Person in lab coat examining test tube
CHAPTER 4 . OUR SMOKELESS SCIENCE

Use Behaviour and Pharmacokinetic Studies

How individuals use the product

Portrait of Dr Sarah Baxter-Wright, Head of Behavioural & Clinical Research, Global Life Sciences
"Our 'use behaviour' studies show that adult consumers use our Smokeless Products in a manner that will not offset the lab-measured reductions in emissions. This use behaviour gives us confidence that we should see reductions in clinical measures when we assess biomarkers of exposure and biomarkers of potential harm."

 

Dr Sarah Baxter-Wright

Head of Behavioural & Clinical Research, Global Life Sciences

Through laboratory tests we understand that the emissions of our Smokeless Products are simpler than cigarette smoke and proven to be less toxic. However, it is important that we understand how adult consumers may use our products to confirm they do not use them in a manner that offsets these reductions. To understand consumer use behaviour we carry out studies that assess:

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Understanding consumer use

01 Puffing Topography

The puffing behaviours of our Heated Products and Vapour Product adult consumers have identified differences and similarities to how adult consumers use cigarettes.[1-4] Our Heated Product adult consumers are reported to take bigger and more frequent puffs. Our data shows that our Vapour Product adult consumers use the product in a similar manner to cigarettes when considering volume and duration. Overall, puffing topography data for Heated Products and Vapour Products clarify how adult consumers use our products; however, we need MLE, PK and ADC data to obtain a more complete picture. 

Table 1 Puffing Topography
Table 2 Mouth hold time

02 Mouth Hold Time

For mouth hold time, our benchmark is Oral Tobacco Products, e.g. snus, because of their history of significant use and epidemiological data showing reduced risk*† of smoking-related disease compared to smoking. Average data for our Oral Nicotine Pouches show that adult consumers hold these in mouth for around half the time of an Oral Tobacco Product consumer.[5]

03 Mouth Level Exposure/Transfer

Our puffing topography and mouth hold time studies also afford us the opportunity to gather data on potential consumer exposure to certain chemicals. Optical and gravimetric measurements of the aerosol and products, respectively, allows for the estimation of how much nicotine has been consumed during use.[1,8,9] Measuring estimated nicotine consumption of our Smokeless Products is important as it provides the opportunity to compare these values to cigarette data. For our Smokeless Products to be effective alternatives to smoking they need to deliver satisfactory levels of nicotine.

 

Overall, while there is large individual variability, our data for mouth level exposure/ transfer gives us confidence that adult smokers can receive levels of nicotine comparable to smoking.

Table 3 Estimated Nicotine Exposure

04 Pharmacokinetic Studies

Inclusive of lab-based studies, we conduct controlled clinical pharmacokinetic (PK) studies to understand the speed and amount of nicotine uptake into the consumer’s bloodstream. Our studies have shown that for our Heated Products and Vapour Products the timing of the peak nicotine concentration in the blood is comparable to cigarette smoking (Figure 1).[10,11] This peak timing is important as it shows through using either a Heated Product or Vapour Product the nicotine experience for a smoker should be familiar.

 

Our Oral Tobacco Products and Oral Nicotine Pouches have different nicotine PK profiles compared to cigarettes (Figure 2). Driven by the different mode of absorption (buccal mucosa vs. lung), the time taken to reach maximum nicotine blood concentration for our Oral Products is slower than a cigarette.[12] This slower nicotine peak delivery for Oral Products provides adult smokers with an unfamiliar initial experience compared to cigarettes. Overall, the unfamiliar nicotine experience of Oral Products can still offer adult smokers an acceptable alternative to cigarettes, as shown by countries such as Sweden.

Table 3 Estimated Nicotine Exposure
Table 3 Estimated Nicotine Exposure

05 Actual Use and Average Daily Consumption

Our final method in understanding consumer use is to conduct an “actual use” home study.[13] Typically, a six-week study that lets adult smokers use our Smokeless Products in their real-life/home environment. During these studies participants record daily data, which includes how much of the product they use. This data allows us to understand a consumer’s average daily consumption of our Smokeless Product, which we compare to their previously reported smoking use. Overall, we find adult consumers use our Smokeless Products at comparable-to-lower levels than their usual cigarettes.

Table 1 Puffing Topography

Footnotes

^The Vapour Product’s study had a fixed number of 10 puffs.

^^Per puff data multiplied by average cigarette puff number for direct Vapour Product versus cigarette comparison

* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.

† Our products as sold in the U.S., including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, are subject to FDA regulation and no reduced-risk claims will be made as to these products without agency clearance.

 

References

[1] Jones, J., et al., A cross-category puffing topography, mouth level exposure and consumption study among Italian users of tobacco and nicotine products. Sci Rep, 2020. 10:12. DOI: 10.1038/s41598-019-55410-5

[2] Prasad., K., et al., Emissions, puffing topography, mouth level exposure and consumption among Japanese users of tobacco heated products. Int J Sci Rep, 2022. 8(11): p. 313-322. DOI: 10.18203/issn.2454-2156.IntJSciRep20222694

[3] Prasad, K., et al., Actual use puffing topography and mouth level exposure to aerosol and nicotine for an evolving series of electronic nicotine delivery systems. Int J Sci Rep, 2022. 8(12): p. 366-76. DOI: 10.18203/issn.2454-2156.IntJSciRep20223033

[4] Edward, L., et al., A consumer use behaviour study to evaluate the average daily consumption, mouth level exposure and puffing topography of regular e-cigarette consumers across a range of e-liquid nicotine levels and flavour categories in New Zealand [unpublished manuscript].

British American Tobacco (BAT), 2024. 

[5] Digard, H., et al., Determination of Nicotine Absorption from Multiple Tobacco Products and Nicotine Gum. Nicotine Tob Res, 2013. 15(1): p. 255–261. DOI: 10.1093/ntr/nts123

[6] Digard, H., et al., Patterns and behaviors of snus consumption in Sweden. Nicotine Tob Res, 2009. 11(10): p. 1175-1181. DOI: 10.1093/ntr/ntp118

[7] Azzopardi, D., et al., Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. Biomarkers, 2023. 28(1): p. 118-129. DOI: 10.1080/1354750X.2022.2148747

[8] Slayford, S.J., and Frost, B.E., A Device to Measure a Smoker's Puffing Topography and Real-Time Puff-by-Puff “Tar” Delivery. Contrib Tob Nicotine Res, 2014. 26(2). DOI: 10.2478/cttr-2014-0011

[9] Troude, V., et al., Human mouth-level transfer rate of menthol, 1.8-cineole and nicotine from Swedish pouched snus. CORESTA SSPT meeting, Seville, 2013. Available at: https://www.coresta.org/sites/default/files/abstracts/2013_ST19_Troude.pdf

[10] Hardie, G., et al., An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy. Sci Rep, 2022. 12(1): 14701. DOI: 10.1038/s41598-022-19167-8

[11] Kanobe, M., et al., Randomized, Crossover Studies of Abuse Liability and Nicotine Pharmacokinetics Assessment of Vuse Alto Electronic Nicotine Delivery Systems. [unpublished manuscript]. British American Tobacco (BAT), 2024

[12] McEwan, M., et al., Plasma Nicotine Pharmacokinetics of Oral Nicotine Pouches Across Varying Flavours and Nicotine Content. Contrib Tob Nicotine Res, 2023. 32(4): p. 130-139. DOI: 10.2478/cttr-2023-0016

[13] Bradford, D. C., et al., The actual use trial: A description of design principles and methods. SelfCare, 2010. 1(4): p. 117-123. Available at: https://selfcarejournal.com/wp-content/uploads/2015/09/Bradford-1.4.117-123.pdf

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