Klemperer Elias M, DeSarno Michael J, Tidey Jennifer W, Gaalema Diann E, Nolder Katya A, Feinstein Marc Jerome P, Wiley Rhiannon C, Higgins Stephen T
UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington, VT, United States of America.
UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington, VT, United States of America.
Prev Med. 2025 Jul 6:108353. doi: 10.1016/j.ypmed.2025.108353.
The U.S. Food and Drug Administration is authorized to implement a nicotine-reducing standard to decrease smoking. Three recent trials found switching to very low nicotine content (VLNC) cigarettes produced the greatest reduction in cigarettes/day and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL, a tobacco-specific carcinogen) among adults from high-risk populations when participants also received preferred- vs tobacco-flavored e-cigarettes. This pooled secondary analysis investigates e-cigarette use frequency as a mechanism driving these effects.
Participants (U.S. adults with affective disorders, adults with opioid use disorder, and reproductive-age females with ≤high-school education) were randomized to 16 weeks of VLNC cigarettes with preferred-flavored e-cigarettes selected from eight options (VLNC+PF; n = 84) or VLNC cigarettes with tobacco-flavored e-cigarettes (VLNC+TF; n = 74) from October 2020-November 2023. General linear models explored whether e-cigarette use frequency (days/week) between Weeks 1-15 mediated effects on Week-16 cigarettes/day and NNAL.
Participants were 40.4 (mean) years old (SD = 11.5), 69.0 % female, 81.0 % white, and smoked 17.3 (mean) cigarettes/day (SD = 9.0) at baseline. The VLNC+PF condition reported more e-cigarette use days/week (LSmean[SEM]): 4.3[±0.4]) than the VLNC+TF condition (LSMean[SEM]: 3.4[±0.5]; F[1151] = 3.9, p < .05) across weeks 1-15. More e-cigarette use days/week predicted greater reductions in mean cigarettes/day (β[SE]: -0.32[±0.05)]; F[1106] = 50.5, p < .01) and NNAL (β[SE]: -0.14[±0.04]; F[1,92] = 12.2, p < .01) at Week-16. E-cigarette use frequency fully mediated the effects of condition on cigarettes/day and partially mediated effects on NNAL.
Greater frequency of e-cigarette use was a mechanism by which preferred-flavor e-cigarettes led to reductions in smoking and tobacco-toxicant exposure, demonstrating the potential for appealing e-cigarettes to reduce harm among high-risk populations who smoke.
美国食品药品监督管理局被授权实施一项降低尼古丁的标准以减少吸烟。最近的三项试验发现，对于高危人群中的成年人，当参与者同时使用偏好口味电子烟与烟草口味电子烟时，改用极低尼古丁含量（VLNC）香烟能使每日吸烟量和4-（甲基亚硝胺基）-1-（3-吡啶基）-1-丁醇（NNAL，一种烟草特异性致癌物）的减少幅度最大。这项汇总的二次分析研究了电子烟使用频率作为驱动这些效果的一种机制。
参与者（患有情感障碍的美国成年人、患有阿片类物质使用障碍的成年人以及高中及以下学历的育龄女性）在2020年10月至2023年11月期间被随机分配，接受16周的VLNC香烟，并搭配从八种口味中选择的偏好口味电子烟（VLNC + PF；n = 84）或搭配烟草口味电子烟的VLNC香烟（VLNC + TF；n = 74）。通用线性模型探讨了第1至15周期间电子烟使用频率（每周天数）是否介导了对第16周每日吸烟量和NNAL的影响。
参与者的平均年龄为40.4岁（标准差 = 11.5），69.0%为女性，81.0%为白人，基线时平均每日吸烟17.3支（标准差 = 9.0）。在第1至15周期间，VLNC + PF组报告的每周电子烟使用天数（最小二乘均值[标准误]）：4.3[±0.4]）多于VLNC + TF组（最小二乘均值[标准误]：3.4[±0.5]；F[1,151] = 3.9，p <.05）。每周更多的电子烟使用天数预示着第16周时平均每日吸烟量（β[标准误]：-0.32[±0.05]；F[1,106] = 50.5，p <.01）和NNAL（β[标准误]：-0.14[±0.04]；F[1,92] = 12.2，p <.01）的更大降幅。电子烟使用频率完全介导了分组对每日吸烟量的影响，部分介导了对NNAL的影响。
更高的电子烟使用频率是偏好口味电子烟导致吸烟量和烟草毒物暴露减少的一种机制，表明有吸引力的电子烟在减少吸烟高危人群危害方面具有潜力。
