Real-world evidence from a prospective longitudinal cohort study assessing changes in smoking behavior among adults using NJOY ACE tobacco and menthol ENDS products.

Abstract

Switching from cigarettes to electronic nicotine delivery systems (ENDS) has the potential to reduce smoking-related harm among adults who smoke (AS). Actual use behavior under real-world conditions can inform the substitution potential of ENDS products. The objective of this study was to assess the transition patterns from combustible cigarettes to use of NJOY ACE® ENDS products. We conducted a prospective longitudinal cohort study (LCS) in a national, purposive sample of 8002 US adults, identity- and age-verified 21 + years, who first used NJOY ACE within the 12-month period prior to Baseline. Participants completed online surveys at Baseline and at 1-, 2-, 3- and 6-month follow-ups. Survey items included demographic characteristics, tobacco product use, and other outcome measures. Adjusted logistic regressions (controlling for relevant covariates) were applied to multiple analytic cohorts - per-protocol (PP) and intent-to-treat (ITT) - to comprehensively determine the association between tobacco and menthol-flavored NJOY ACE use and the association between flavor and past 30-day point prevalence smoking abstinence (30dPPA). Overall PP/ITT switching rates (30dPPA) among participants who used tobacco or menthol flavored product at the 3- and 6-month time points were 22.0%/15.1% and 36.2%/23.6%, respectively. Menthol-flavored product use was associated with significantly higher switching rates than tobacco-flavored use across the different analytic cohorts (1.12-1.55x higher). Covariate-adjusted logistic regressions demonstrated consistently higher odds of 3-month 30dPPA (Odds Ratio = 1.33-1.50) for menthol- compared to tobacco-flavored products. Real-world data demonstrated that availability of NJOY ACE results in robust switching from cigarettes and therefore can manifest a public health benefit.