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Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

Publication ,  Journal Article
Donny, EC; Denlinger, RL; Tidey, JW; Koopmeiners, JS; Benowitz, NL; Vandrey, RG; al'Absi, M; Carmella, SG; Cinciripini, PM; Dermody, SS; Le, CT ...
Published in: N Engl J Med
October 2015

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 2015

Volume

373

Issue

14

Start / End Page

1340 / 1349

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Tobacco Use Disorder
  • Tobacco Products
  • Tars
  • Substance Withdrawal Syndrome
  • Nicotine
  • Nicotiana
  • Linear Models
  • Inhalation Exposure
 

Citation

APA
Chicago
ICMJE
MLA
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Donny, E. C., Denlinger, R. L., Tidey, J. W., Koopmeiners, J. S., Benowitz, N. L., Vandrey, R. G., … Hatsukami, D. K. (2015). Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J Med, 373(14), 1340–1349. https://doi.org/10.1056/NEJMsa1502403
Donny, Eric C., Rachel L. Denlinger, Jennifer W. Tidey, Joseph S. Koopmeiners, Neal L. Benowitz, Ryan G. Vandrey, Mustafa al’Absi, et al. “Randomized Trial of Reduced-Nicotine Standards for Cigarettes.N Engl J Med 373, no. 14 (October 2015): 1340–49. 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. N Engl J Med. 2015 Oct;373(14):1340–9.
Donny, Eric C., et al. “Randomized Trial of Reduced-Nicotine Standards for Cigarettes.N Engl J Med, vol. 373, no. 14, Oct. 2015, pp. 1340–49. Pubmed, doi:10.1056/NEJMsa1502403.
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. Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J Med. 2015 Oct;373(14):1340–1349.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 2015

Volume

373

Issue

14

Start / End Page

1340 / 1349

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Tobacco Use Disorder
  • Tobacco Products
  • Tars
  • Substance Withdrawal Syndrome
  • Nicotine
  • Nicotiana
  • Linear Models
  • Inhalation Exposure