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Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems. In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-cigarettes; medicinal nicotine). Group differences in the primary outcomes (cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685). Among 438 randomized participants (mean standard deviation (SD), range age, 44.5 11.9, 20-73 years, 225 51.4% women, 282 64.4% White and 339 77.4% trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean SD, 7.05 7.88 vs. 12.95 9.07, adjusted mean difference, -6.21 95% CI, -7.66 to -4.75, P < 0.0001) and greater smoke-free days during intervention (mean SD, 18.59 27.97 vs. 5.06 13.77, adjusted rate ratio, 4.25 95% CI, 2.58-6.98, P < 0.0001). A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health. U.S. NIH/FDA U54DA03165.
Hatsukami et al. (Mon,) studied this question.