Randomized trial of reduced-nicotine standards for cigarettes
The article by Donny et al.[1] and the accompanying Perspective article by Fiore and Baker[2] have prompted considerable discussion. Until the results of this study are replicated in a population that more closely resembles average smokers and has a longer follow-up period, these discussions are premature.
The study design appears to have involved recruitment of participants who were, as compared with average smokers, less dependent on nicotine and showed no compensatory behavior when nicotine levels were reduced. As shown in Figure 1 of the article, the number of cigarettes smoked by participants who received cigarettes with baseline amounts of nicotine increased from 15 to 20, whereas the number smoked by those who received cigarettes with the lowest amount of nicotine remained at baseline levels.
Although none of the participants stated an interest in quitting smoking, a better measure of the participants’ intention would have been “no intention to quit smoking in the next 6 months.” The majority of current smokers are in this category.[3] Future exploration of this issue and related issues also needs to take into account that the demographic characteristics of smokers have changed: 50% of cigarettes smoked are smoked by persons with mental illness.[4]
[1] Donny EC, Denlinger RL, Tidey JW, et al. Randomized trial of reduced-nicotine standards for cigarettes. N Engl J Med 2015;373:1340-1349
[2] Fiore M, Baker T. Reduced-nicotine cigarettes — a promising regulatory pathway. N Engl J Med 2015;373:1289-1291
[3] Rigotti NA. Strategies to help a smoker who is struggling to quit. JAMA2012;308:1573-1580
[4] Agaku IT, King BA, Husten CG, et al. Tobacco product use among adults — United States, 2012–2013. MMWR Morb Mortal Wkly Rep 2014;63:542-547
