Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trialResearch in context

Autor: Dorothy K. Hatsukami, Joni A. Jensen, Dana Mowls Carroll, Xianghua Luo, Lori G. Strayer, Qing Cao, Stephen S. Hecht, Sharon E. Murphy, Steven G. Carmella, Rachel L. Denlinger-Apte, Suzanne Colby, Andrew A. Strasser, F. Joseph McClernon, Jennifer Tidey, Neal L. Benowitz, Eric C. Donny
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: The Lancet Regional Health. Americas, Vol 35, Iss , Pp 100796- (2024)
Druh dokumentu: article
ISSN: 2667-193X
DOI: 10.1016/j.lana.2024.100796
Popis: Summary: Background: 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. Methods: 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). Findings: 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
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