Randomized trial of reduced-nicotine standards for cigarettes

Eric C. Donny, 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 & 3 others Andrew A. Strasser, Hilary Tindle, Dorothy K. Hatsukami

Research output: Contribution to journalArticle

124 Citations (Scopus)

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.).

Original languageEnglish (US)
Pages (from-to)1340-1349
Number of pages10
JournalNew England Journal of Medicine
Volume373
Issue number14
DOIs
StatePublished - Oct 1 2015

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Nicotine
Tobacco Products
Tobacco Use Disorder
Smoking
United States Food and Drug Administration
Tobacco
National Institute on Drug Abuse (U.S.)
Carbon Monoxide
Random Allocation

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Randomized trial of reduced-nicotine standards for cigarettes. / 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.

In: New England Journal of Medicine, Vol. 373, No. 14, 01.10.2015, p. 1340-1349.

Research output: Contribution to journalArticle

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 2015, 'Randomized trial of reduced-nicotine standards for cigarettes', New England Journal of Medicine, vol. 373, no. 14, pp. 1340-1349. https://doi.org/10.1056/NEJMsa1502403
Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, Vandrey RG et al. Randomized trial of reduced-nicotine standards for cigarettes. New England Journal of Medicine. 2015 Oct 1;373(14):1340-1349. https://doi.org/10.1056/NEJMsa1502403
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. / Randomized trial of reduced-nicotine standards for cigarettes. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 14. pp. 1340-1349.
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AU - Donny, Eric C.

AU - Denlinger, Rachel L.

AU - Tidey, Jennifer W.

AU - Koopmeiners, Joseph S.

AU - Benowitz, Neal L.

AU - Vandrey, Ryan G.

AU - Al'Absi, Mustafa

AU - Carmella, Steven G.

AU - Cinciripini, Paul M.

AU - Dermody, Sarah S.

AU - Drobes, David J.

AU - Hecht, Stephen S.

AU - Jensen, Joni

AU - Lane, Tonya

AU - Le, Chap T.

AU - McClernon, F. Joseph

AU - Montoya, Ivan D.

AU - Murphy, Sharon E.

AU - Robinson, Jason D.

AU - Stitzer, Maxine L.

AU - Strasser, Andrew A.

AU - Tindle, Hilary

AU - Hatsukami, Dorothy K.

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N2 - 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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