Randomized Trial of Reduced-Nicotine Standards for Cigarettes.
Randomized Trial of Reduced-Nicotine Standards for Cigarettes.
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DOI：
10.1056/nejmsa1502403
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发表时间：
2015-10
期刊：
影响因子：
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通讯作者：
Hatsukami DK
中科院分区：
文献类型：
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作者：
Donny EC;Denlinger RL;Tidey JW;Koopmeiners JS;Benowitz NL;Vandrey RG;al'Absi M;Carmella SG;Cinciripini PM;Dermody SS;Drobes DJ;Hecht SS;Jensen J;Lane T;Le CT;McClernon FJ;Montoya ID;Murphy SE;Robinson JD;Stitzer ML;Strasser AA;Tindle H;Hatsukami DK
美国食品和药物管理局可以制定降低香烟尼古丁含量的标准。 2013 年 6 月至 2014 年 7 月期间，我们在 10 个地点进行了双盲、平行、随机临床试验。资格标准包括年龄 18 岁或以上、每天吸 5 支或更多烟、目前没有戒烟兴趣。参与者被随机分配吸烟 6 周，要么是他们常用的香烟品牌，要么是免费提供的六种研究香烟中的一种。研究香烟的尼古丁含量从每克烟草 15.8 毫克（商业品牌的典型）到每克 0.4 毫克不等。主要结果是第 6 周每天吸烟的数量。共有 840 名参与者接受了随机分组，其中 780 名完成了为期 6 周的研究。在第 6 周期间，随机分配到每克烟草含有 2.4、1.3 或 0.4 毫克尼古丁的香烟的参与者（分别为 16.5、16.3 和 14.9 支香烟）的平均每天吸烟数量低于随机分配到常用品牌或每克含有 15.8 毫克尼古丁的香烟的参与者（分别为 22.2 和 21.3 支香烟； P<0.001）。分配每克 5.2 毫克香烟的参与者平均每天吸 20.8 支香烟，这与吸对照香烟的参与者的平均数量没有显着差异。与对照香烟相比，尼古丁含量较低的香烟减少了对尼古丁的接触和依赖，以及戒烟期间的渴望，而不会显着增加过期一氧化碳水平或总抽吸量，这表明补偿最小。各组之间的不良事件一般较轻微且相似。在这项为期 6 周的研究中，与标准尼古丁香烟相比，低尼古丁香烟减少了尼古丁暴露和依赖以及吸烟数量。 （由国家药物滥用研究所和食品药品监督管理局烟草制品中心资助；ClinicalTrials.gov 编号，NCT01681875。）
The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.)