Krautter George R, Chen Peter X, Borgerding Michael F
R.J. Reynolds Tobacco Company, Winston-Salem, NC, USA.
R.J. Reynolds Tobacco Company, Winston-Salem, NC, USA.
Regul Toxicol Pharmacol. 2015 Mar;71(2):186-97. doi: 10.1016/j.yrtph.2014.12.016. Epub 2014 Dec 27.
The objectives of this clinical study were to evaluate changes in tobacco product use behavior and levels of selected biomarkers of exposure (BOEs) for smokers who switched to one of six conditions during clinical confinement: exclusive use of; Camel Snus, Sticks, Strips or Orbs, controlled Dual use of cigarettes and Camel Snus, or tobacco abstinence. The controlled Dual use (DU) condition mandated a 60% reduction in cigarettes smoked per day (CPD). 167 healthy U.S. male and female smokers were randomized to the six groups (n=25-30/group). Subjects smoked their usual brand of cigarette for 1 day prior to switching to their designated intervention condition. Levels of thirty-two BOEs in plasma, whole blood, urine and feces were determined before and after switching. Questionnaires that scored nicotine dependence and withdrawal discomfort were also administered. After 5 days, exclusive Snus, Sticks, Strips, or Orbs use averaged 6.1, 5.9, 13.5, and 8.5 units/day, respectively. DU subjects smoked 7.6 CPD and used 3.2 Snus pouches/day, on average. After 5 days, substantial reductions of most biomarkers, including nicotine, were observed in all groups. Toxicant exposures were similar to being tobacco abstinent after switching exclusively to Camel Snus, Sticks, Strips or Orbs. DU reductions were more modest.
这项临床研究的目的是评估在临床隔离期间切换至六种情况之一的吸烟者的烟草制品使用行为变化以及选定的暴露生物标志物（BOEs）水平：仅使用骆驼鼻烟、烟支、烟条或烟珠；香烟与骆驼鼻烟的受控双重使用；或戒烟。受控双重使用（DU）情况要求每日吸烟量（CPD）减少60%。167名健康的美国男性和女性吸烟者被随机分为六组（每组n = 25 - 30）。在切换至指定的干预情况之前，受试者吸了1天他们常用品牌的香烟。在切换前后测定血浆、全血、尿液和粪便中32种BOEs的水平。还发放了对尼古丁依赖性和戒断不适进行评分的问卷。5天后，仅使用鼻烟、烟支、烟条或烟珠的平均使用量分别为每天6.1、5.9、13.5和8.5单位。DU组受试者平均每天吸烟7.6支，使用3.2袋鼻烟。5天后，所有组中大多数生物标志物（包括尼古丁）都有大幅下降。仅切换至骆驼鼻烟、烟支、烟条或烟珠后，毒物暴露水平与戒烟时相似。DU组的下降幅度较小。
