161: Comparison of Nicotine Pharmacokinetic & Subjective Profiles of Three Modern Oral Nicotine Products & a Snus Product

Statement of Purpose, Innovation or Hypothesis: Modern Oral Nicotine Products (MONP) form an expanding category which offer potentially reduced harm (i.e., reduced exposure to tobacco-associated toxicants) nicotine delivery. In order to provide an acceptable alternative for current adult users of tobacco products, it is important to offer a range of nicotine strengths to suit different consumer preferences. This study aimed to assess the nicotine pharmacokinetic (blood plasma nicotine) and subjective effects of three MONP, Zone X #5 slim (14mg nicotine/pouch), Zone X #5 (16mg) and Zone X #6 (20mg) and compare these to a tobacco snus product (Skruf Slim Fresh #5 (16.6mg)) in adult snus or nicotine pouch users. The study also assessed adverse event and tolerability profiles of the products.

Description of Methods & Materials: This was a randomised, open-label, cross-over, confinement study approved by the Swedish Ethical Review Authority (SERA), carried out in accordance with the ethical principles outlined in the Declaration of Helsinki, International Conference of Harmonisation (ICH)/ Good Clinical Practice (GCP), European Union Clinical Trials Directive and applicable local regulatory requirements. Twenty-seven male (n = 16) and female (n = 11) adult snus and nicotine pouch users participated in the study, which was carried out at a single clinical site in Sweden. Subjects attended two clinic visits, a screening and a 4-day confinement period; follow-up telephone calls with subjects were also carried out a week after the last study product use. All subjects provided written informed consent prior to study commencement. Clinical Trial identifier: NCT05452278 (clinicaltrials.gov).

Data & Results: The ZoneX #6 (20mg nicotine) product delivered significantly higher levels of nicotine to the blood compared to the other study products in the pharmacokinetic parameters assessed; however, all products exhibited similar effects on reductions in urge to use nicotine during a controlled product use session. Furthermore, the ZoneX products generally scored higher on a 7-point Likert product evaluation scale for satisfaction, psychological reward, aversion and relief, assessed 8h following the start of the product use session, compared to the snus product. There was some influence on pouch size (slim vs. regular) on nicotine uptake, however, further exploration is required. All study products demonstrated good short-term tolerability profiles, with no serious adverse events observed.

Interpretation, Conclusion or Significance: Overall, MONP may offer adult users of oral tobacco products a potentially harm-reduced and acceptable alternative for consuming nicotine.

Disclosures: All authors were employees of Imperial Brands or it subsidiaries at the time of the study.

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