whatIF? Consulting Ltd, The Crispin, Burr Street, Harwell, OX11 0DT, UK.
McKinney Regulatory Science Advisors, LLC, 4940 Old Main Street, Unit 603, Henrico, VA, 23231, USA.
Harm Reduct J. 2022 Jun 2;19(1):57. doi: 10.1186/s12954-022-00638-0.
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.
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.
Mean [SD] plasma nicotine C 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] AUC (range 569.7 [327.29] to 628.6 [408.99] minng/ml for BIDI Stick ENDS and 747.1 [325.48] minng/ml for UB cigarettes) and median T (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 C, AUC, and median T 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 C and AUC but not for T.
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.
ClinicalTrials.gov (identifier number NCT05072925).
评估电子烟尼古丁药代动力学对于了解其提供替代吸烟的能力至关重要。主观效应数据也对此有很大的帮助。BIDI 棒是一种一次性电子烟产品，含有 59mg/ml 的尼古丁苯甲酸盐和各种口味。
在这项研究中，我们评估了 BIDI 棒电子烟的 6 种口味变体在成年吸烟者中的尼古丁药代动力学和主观效应，与香烟和一种比较器电子烟（JUUL，59mg/ml 尼古丁，弗吉尼亚烟草味）进行了比较。在每个 8 次研究访问中，18 名志愿吸烟者随机使用他们通常的香烟品牌（UB）、BIDI 棒电子烟或比较器电子烟（JUUL，59mg/ml 尼古丁，弗吉尼亚烟草味），在控制（10 口，30 秒间隔）和自由（60 分钟）抽吸期间。在不同的时间点采集血样，并进行主观效应问卷调查。
BIDI 棒电子烟与 UB 香烟之间的平均[标准差]血浆尼古丁 C 无显著差异（BIDI 棒冬季的范围为 15.3[9.90]ng/ml，BIDI 棒经典的范围为 17.6[9.00]ng/ml）。平均[标准差]AUC（BIDI 棒电子烟的范围为 569.7[327.29]至 628.6[408.99]minng/ml，UB 香烟的范围为 747.1[325.48]minng/ml）和中位 T（BIDI 棒电子烟和 UB 香烟的范围均为 5-7 分钟）值也无显著差异，而主观效应测量也与 BIDI 棒电子烟和 UB 香烟相似。JUUL 电子烟的平均[标准差]血浆尼古丁 C、AUC 和中位 T 分别为 6.8[4.13]ng/ml、243.6[179.04]min*ng/ml 和 5 分钟。与所有 BIDI 棒电子烟和 UB 香烟相比，这些值在 C 和 AUC 方面均有显著差异，但在 T 方面没有差异。
BIDI 棒电子烟向使用者输送尼古丁的能力与 UB 可燃香烟相当，高于 JUUL 电子烟，并且也产生了相似的主观效应，如满足感和缓解感。因此，BIDI 棒电子烟可能是当前吸烟者替代香烟的一种令人满意的选择，并可能支持他们戒烟。
ClinicalTrials.gov（标识符编号 NCT05072925）。
