Donny Eric C, Denlinger Rachel L, Tidey Jennifer W, Koopmeiners Joseph S, Benowitz Neal L, Vandrey Ryan G, al'Absi Mustafa, Carmella Steven G, Cinciripini Paul M, Dermody Sarah S, Drobes David J, Hecht Stephen S, Jensen Joni, Lane Tonya, Le Chap T, McClernon F Joseph, Montoya Ivan D, Murphy Sharon E, Robinson Jason D, Stitzer Maxine L, Strasser Andrew A, Tindle Hilary, Hatsukami Dorothy K
From the Departments of Psychology (E.C.D., R.L.D., S.S.D., T.L.) and Medicine (H.T.), University of Pittsburgh, Pittsburgh; the Center for Alcohol and Addiction Studies, Brown University, Providence, RI (J.W.T.); the Division of Biostatistics, School of Public Health (J.S.K., C.T.L.), the Departments of Biochemistry, Molecular Biology, and Biophysics (S.E.M.) and Psychiatry (D.K.H.) and the Masonic Cancer Center (J.S.K., S.G.C., S.S.H., J.J., C.T.L., S.E.M., D.K.H.), University of Minnesota, Minneapolis, and the University of Minnesota Medical School, Duluth (M.A.) - all in Minnesota; the Departments of Medicine and Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco (N.L.B.); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore (R.G.V., M.L.S.), and National Institute on Drug Abuse, Bethesda (I.D.M.) - both in Maryland; the Department of Behavioral Science, University of Texas M.D. Anderson Cancer Center, Houston (P.M.C., J.D.R.); the Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL (D.J.D.); the Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC (F.J.M.); and the Department of Psychiatry, Perelman School of Medicine, and Abramson Cancer Center, University of Pennsylvania, Philadelphia (A.A.S.).
N Engl J Med. 2015 Oct;373(14):1340-9. doi: 10.1056/NEJMsa1502403.
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.).
美国食品药品监督管理局能够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个地点进行了一项双盲、平行、随机临床试验。入选标准包括年龄在18岁及以上、每天吸烟5支或更多、目前无意戒烟。参与者被随机分配，连续6周吸食其常用品牌香烟或六种免费提供的试验用香烟之一。试验用香烟的尼古丁含量范围为每克烟草15.8毫克（商业品牌的典型含量）至每克0.4毫克。主要结局是第6周时每天的吸烟支数。
共有840名参与者接受随机分组，780人完成了为期6周的研究。在第6周时，随机分配到每克烟草含2.4毫克、1.3毫克或0.4毫克尼古丁香烟的参与者，每天的平均吸烟支数（分别为16.5支、16.3支和14.9支）低于随机分配到常用品牌香烟或每克含15.8毫克尼古丁香烟的参与者（分别为22.2支和21.3支；P<0.001）。分配到每克含5.2毫克尼古丁香烟的参与者每天平均吸烟20.8支，与吸食对照香烟者的平均吸烟支数无显著差异。与对照香烟相比，尼古丁含量较低的香烟可减少对尼古丁的接触和依赖，以及戒烟期间的烟瘾，且不会显著提高呼出一氧化碳水平或总吸量，表明补偿作用极小。不良事件一般较轻，且各组之间相似。
在这项为期6周的研究中，低尼古丁香烟与标准尼古丁香烟相比，可降低尼古丁接触和依赖以及吸烟支数。（由美国国立药物滥用研究所和美国食品药品监督管理局烟草制品中心资助；临床试验注册号，NCT01681875。）
