A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI® stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers

Ian M Fearon, Karin Gilligan, Ryan G N Seltzer, Willie McKinney, Ian M Fearon, Karin Gilligan, Ryan G N Seltzer, Willie McKinney

Abstract

Background: Nicotine pharmacokinetic assessments of electronic nicotine delivery systems (ENDS) are crucial to understand their ability to provide an alternative to cigarette smoking. Subjective effects data also strongly contribute to this understanding. The BIDI® Stick is a disposable ENDS product which contains 59 mg/ml nicotine benzoate salt and various flavours.

Methods: In this study, we assessed nicotine pharmacokinetics and subjective effects of 6 flavour variants of BIDI® Stick ENDS in adult smokers, compared to cigarettes and a comparator ENDS product. During each of eight study visits, 18 volunteer smoker subjects randomly used one of either their usual brand (UB) of cigarette, a BIDI® Stick ENDS, or a comparator ENDS (JUUL 59 mg/ml nicotine with Virginia Tobacco flavour), during both controlled (10 puffs, 30 s apart) and ad libitum (60 min) puffing sessions. Blood samples were collected at various time points and subjective effects questionnaires were administered.

Results: Mean [SD] plasma nicotine Cmax 0-120 was not significantly different between BIDI® Stick ENDS with any flavour (range 15.3 [9.90] ng/ml for BIDI® Stick Winter to 17.6 [9.00] ng/ml for BIDI® Stick Classic) and UB cigarettes (16.2 [9.17] ng/ml). Mean [SD] AUC0-120 (range 569.7 [327.29] to 628.6 [408.99] min*ng/ml for BIDI® Stick ENDS and 747.1 [325.48] min*ng/ml for UB cigarettes) and median Tmax 0-120 (range 5-7 min for all BIDI® Stick ENDS and UB cigarettes) values were also not significantly different between BIDI® Stick ENDS and UB cigarettes, while subjective effects measures were also similar between BIDI® Stick ENDS and UB cigarettes. Mean [SD] plasma nicotine Cmax 0-120, AUC0-120, and median Tmax 0-120 were 6.8 [4.13] ng/ml, 243.6 [179.04] min*ng/ml, and 5 min, respectively, for JUUL ENDS. These values were significantly different compared with those for all BIDI® Stick ENDS and UB cigarettes for both Cmax 0-120 and AUC0-120 but not for Tmax 0-120.

Conclusions: BIDI® Stick ENDS delivered nicotine to users comparably to their UB combustible cigarette and higher than JUUL ENDS, and also elicited similar subjective effects such as satisfaction and relief. Thus, the BIDI® Stick ENDS may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.

Trial registration: ClinicalTrials.gov (identifier number NCT05072925).

Keywords: Cigarette; Electronic nicotine delivery system; Nicotine; Pharmacokinetics; Smoking; Subjective effects.

Conflict of interest statement

IMF is an independent consultant contracted to ENDS and tobacco product manufacturers to provide scientific and regulatory support for clinical and behavioural studies. RGNS is an independent consultant who provides statistical support to ENDS manufacturers. KG is an employee of, and WM is the President of, McKinney Regulatory Science Advisors, LLC who are contracted to provide scientific and regulatory support to ENDS and tobacco product manufacturers.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Meanbaseline-adjusted plasma nicotine concentration by time. N = 17–18 in each case. Solid black bars below the plot indicate the controlled (0–5 min) and ad libitum (120–180 min) puffing sessions. Errors bars have been omitted for clarity; for variability estimates, refer to Table 1. UB, usual brand; VT, Virginia Tobacco

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