Comparing the Effectiveness, Tolerability, and Acceptability of Heated Tobacco Products and Refillable Electronic Cigarettes for Cigarette Substitution (CEASEFIRE): Randomized Controlled Trial

Abstract

Background People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. Objective We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. Methods We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide–confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. Results A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation. Conclusions Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. Trial Registration ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748

Switching Behavior and Changes in Smoking Behavior by Menthol Cigarette Preference and Menthol Heated Tobacco Product Use Among Adults Who Smoke Cigarettes: An Actual Use Study

“…Additionally, dual use incorporates a wide range of use behaviors, with varying proportions of use across the two or more tobacco products used by an individual (44). Dual use behavior has often been shown to be a transitional period when switching from combusted cigarettes to ENDS and HTP (25,(45)(46)(47)(48). It is possible that some of the dual use observed in the current study may have occurred during such a transitional period among those needing longer than six weeks to completely switch away from combusted cigarettes.…”

Effectiveness of smoking cessation on the high-risk population of lung cancer with early screening: a systematic review and meta-analysis of randomized controlled trials until January 2022

“…The present research revealed that in most studies, researchers mostly take the smoking cessation rate as the main outcome indicators [ 43 , 44 ], such as the 7-day smoking cessation rate and the continuous smoking cessation rate. The 7-day quitting rate refers to the quitting rate within 7 days before the follow-up, and the continuous quitting rate refers to never smoking during the period from the date of quitting smoking to the end of the follow-up.…”

A multicenter prospective randomized controlled trial investigating the effects of combustion-free nicotine alternatives on cardiovascular risk factors and metabolic parameters in individuals with type 2 diabetes who smoke: the DiaSmokeFree study protocol

“…Although not authorized as medications for smoking cessation, combustion-free technologies for nicotine delivery, such as e-cigarettes (ECs) and heated tobacco products (HTPs), have become de facto harm reduction tools from cigarette smoke [ 18 – 20 ] and aids for quitting smoking [ 21 , 22 ]. Currently, there is insufficient evidence to recommend use of ECs or HTPs as a tobacco cigarette substitute among people with diabetes who smoke, and there are no long-term studies assessing cardiovascular risk or the impact on metabolic parameters in people with diabetes who use these technologies.…”