Eric C Donny1, Rachel L Denlinger, Jennifer W Tidey, Joseph S Koopmeiners, Neal L Benowitz, Ryan G Vandrey, Mustafa al'Absi, Steven G Carmella, Paul M Cinciripini, Sarah S Dermody, David J Drobes, Stephen S Hecht, Joni Jensen, Tonya Lane, Chap T Le, F Joseph McClernon, Ivan D Montoya, Sharon E Murphy, Jason D Robinson, Maxine L Stitzer, Andrew A Strasser, Hilary Tindle, Dorothy K Hatsukami. 1. 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.).
Abstract
BACKGROUND: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).
RCT Entities:
BACKGROUND: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).
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