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.

Introduction:
This text describes a clinical study that assessed the nicotine pharmacokinetics and subjective effects of the BIDI® Stick ENDS, a disposable electronic nicotine delivery system (ENDS), compared to combustible cigarettes and a comparator ENDS product in adult smokers. The study included controlled and ad libitum puffing sessions and measured plasma nicotine concentrations, mass loss, and subjective effects.

Key Points:

* The study included 18 adult smokers who were current users of at least 10 factory-manufactured cigarettes a day with a Federal Trade Commission tar yield of 8-10 mg.
* Six BIDI® Stick ENDS with different flavors and a comparator ENDS product (JUUL 59 mg/ml nicotine with Virginia Tobacco flavor) were assessed.
* Subjects underwent nicotine pharmacokinetic and subjective effects assessments during eight clinic visits, with each visit separated by at least two days.
* Plasma nicotine levels were measured using a validated reversed-phase hPLC with MS/MS method.
* Mass loss was calculated by subtracting the mass post-use from the mass pre-use.
* Subjective effects were assessed using the 21-item Product Evaluation Scale.
* The study found that the BIDI® Stick ENDS delivered nicotine to users comparably to their usual brand (UB) combustible cigarette and higher than the JUUL ENDS.
* The subjective effects measured were also similar between the BIDI® Stick ENDS and UB cigarettes.

Main Message:
The study suggests that the BIDI® Stick ENDS may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking. however, more research is needed to confirm these findings and to assess the long-term health effects of using the BIDI® Stick ENDS. It is important to note that while the BIDI® Stick ENDS delivered nicotine at similar levels to combustible cigarettes, it still contains harmful chemicals and should not be considered a safe alternative to smoking.

Fearon IM, Gilligan K, Seltzer RGN, McKinney W. 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. harm reduction journal. 2022;19(1):57. doi:10.1186/s12954-022-00638-0