1. Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.
- Author
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Hatsukami, Dorothy, Jensen, Joni, Carroll, Dana, Luo, Xianghua, Strayer, Lori, Cao, Qing, Hecht, Stephen, Murphy, Sharon, Carmella, Steven, Denlinger-Apte, Rachel, Colby, Suzanne, Strasser, Andrew, McClernon, F, Tidey, Jennifer, Benowitz, Neal, and Donny, Eric
- Subjects
Cigarettes ,Electronic cigarettes ,Nicotine ,Nicotine delivery systems ,Reduced nicotine cigarettes ,Smoking cessation ,Tobacco ,Tobacco control ,Tobacco policy ,Tobacco product regulations - Abstract
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
- Published
- 2024