■减少香烟成瘾性有可能避免全球每年数百万与烟草有关的死亡。大量减少香烟中的尼古丁会减少香烟的消耗,但是,当其他含尼古丁的产品可用时,没有大型临床试验确定低尼古丁香烟的效果。这项研究的目的是在替代尼古丁输送系统的可用性的背景下,研究减少尼古丁香烟的影响。
■在美国六个站点中,开放标签,平行臂研究,吸烟者被随机分配到每克烟草含有0.4毫克或15.8毫克尼古丁的实验市场12周;所有人都可以使用未燃烧的替代尼古丁递送系统(例如,电子烟;药用尼古丁)。主要结果的群体差异(每天吸烟,无烟天数)使用线性和负二项回归进行检查,分别(试用注册:NCT03272685)。
■在438名随机参与者中(平均值[标准差(SD),range]年龄,44.5[11.9,20-73]年,225名妇女[51.4%],282[64.4%]怀特和339[77.4%]试验完成者),那些在0.4毫克与在干预结束时,每天15.8毫克尼古丁香烟的情况显着降低香烟量(平均值[SD],7.05[7.88]vs.12.95[9.07],调整后的平均差,-6.21[95%CI,-7.66至-4.75],P<0.0001)和干预期间更多的无烟天数(平均值[SD],18.59[27.97]vs.5.06[13.77],调整后的费率比率,4.25[95%CI,2.58-6.98],P<0.0001)。
■在获得其他未燃烧的尼古丁产品的背景下,降低尼古丁的香烟标准有可能使公众健康受益。
■美国NIH/FDAU54DA03165。
UNASSIGNED: Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in
cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine
cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine
cigarettes in the context of the availability of alternative nicotine delivery systems.
UNASSIGNED: In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-
cigarettes; medicinal nicotine). Group differences in the primary outcomes (
cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685).
UNASSIGNED: Among 438 randomized participants (mean [standard deviation (SD), range] age, 44.5 [11.9, 20-73] years, 225 [51.4%] women, 282 [64.4%] White and 339 [77.4%] trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean [SD], 7.05 [7.88] vs. 12.95 [9.07], adjusted mean difference, -6.21 [95% CI, -7.66 to -4.75], P < 0.0001) and greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58-6.98], P < 0.0001).
UNASSIGNED: A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health.
UNASSIGNED: U.S. NIH/FDA U54DA03165.