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NAQC Newsroom: Research

Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

Monday, October 19, 2015  
Posted by: Natalia Gromov
Eric C. Donny, Ph.D., Rachel L. Denlinger, B.S., Jennifer W. Tidey, Ph.D., Joseph S. Koopmeiners, Ph.D., Neal L. Benowitz, M.D., Ryan G. Vandrey, Ph.D., Mustafa al’Absi, Ph.D., Steven G. Carmella, B.A., Paul M. Cinciripini, Ph.D., Sarah S. Dermody, M.S., David J. Drobes, Ph.D., Stephen S. Hecht, Ph.D., Joni Jensen, M.P.H., Tonya Lane, M.Ed., Chap T. Le, Ph.D., F. Joseph McClernon, Ph.D., Ivan D. Montoya, M.D., M.P.H., Sharon E. Murphy, Ph.D., Jason D. Robinson, Ph.D., Maxine L. Stitzer, Ph.D., Andrew A. Strasser, Ph.D., Hilary Tindle, M.D., M.P.H., and Dorothy K. Hatsukami, Ph.D.
Randomized Trial of Reduced-Nicotine Standards for Cigarettes.
N Engl J Med 2015; 373:1340-1349October 1, 2015DOI: 10.1056/NEJMsa1502403
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.
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; number, NCT01681875.)

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