ICON PLC, South County Business Park, Leopardstown, Dublin 18, Ireland.
Imperial Brands PLC, 121 Winterstoke Road, Bristol, BS3 2LL, UK.
Sci Rep. 2023 Jun 3;13(1):9037. doi: 10.1038/s41598-023-36259-1.
Nicotine delivery and subjective effects are determinants of the ability of potentially less harmful tobacco products such as heated tobacco products (HTPs) to support adult smokers in switching away from cigarettes, and therefore to support tobacco harm reduction. This open-label, randomised, crossover, clinical study in 24 healthy adult smokers study assessed nicotine pharmacokinetics and subjective effects of the Pulze Heated Tobacco System (HTS; Pulze HTP device and three iD stick variants-Intense American Blend, Regular American Blend and Regular Menthol) compared with subjects' usual brand cigarettes (UBC). C and AUC were highest for UBC and significantly lower for each Pulze HTS variant. C and AUC were significantly higher for Intense American Blend compared with Regular American Blend, while AUC was significantly higher for Intense American Blend compared with Regular Menthol. Median T was lowest (i.e., nicotine delivery was fastest) for subjects' usual brand cigarettes and similar across the iD stick variants, although no between-product differences were statistically significant. All study products reduced urges to smoke; this effect was greatest for cigarettes although this was not statistically significant. Product evaluation scores for each Pulze HTS variant in the domains of 'satisfaction', 'psychological reward' and 'relief' were similar, and lower than those for UBC. These data demonstrate that the Pulze HTS effectively delivers nicotine and generates positive subjective effects, including satisfaction and reduced urge to smoke. This supports the conclusion that the Pulze HTS may be an acceptable alternative to cigarettes for adult smokers while having a lower abuse liability than cigarettes.
尼古丁的传递和主观效应是决定潜在危害性较小的烟草产品（如加热烟草产品（HTP））能否帮助成年吸烟者戒烟、从而支持减少烟草危害的因素。这项在 24 名健康成年吸烟者中开展的开放性、随机、交叉、临床研究，评估了与受试者常用品牌香烟（UBC）相比，Pulze 加热烟草系统（HTS；Pulze HTP 设备和三种 iD 棒变体——浓郁美式混合、常规美式混合和常规薄荷醇）的尼古丁药代动力学和主观效应。C 和 AUC 最高的是 UBC，而每个 Pulze HTS 变体均显著降低。与常规美式混合相比，Intense American Blend 的 C 和 AUC 更高，而与常规薄荷醇相比，Intense American Blend 的 AUC 更高。T 中位数最低（即尼古丁传递最快）是受试者常用品牌香烟，而在 iD 棒变体之间相似，尽管产品之间没有统计学意义上的差异。所有研究产品均降低了吸烟的冲动；尽管这在统计学上并不显著，但香烟的效果最大。在“满意度”、“心理奖励”和“缓解”等领域，每个 Pulze HTS 变体的产品评估得分相似，且低于 UBC。这些数据表明，Pulze HTS 有效地传递了尼古丁并产生了积极的主观效应，包括满足感和降低吸烟冲动。这支持了这样的结论，即 Pulze HTS 可能是成年吸烟者替代香烟的可接受选择，而且其滥用潜力低于香烟。
