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

• DOI: 10.2196/preprints.42628
• Publication Date: 2022-09-14T18:50:03Z
• Authors: Pasquale Caponnetto; Davide Campagna; Marilena Maglia; Francesca Benfatto; Rosalia Emma; Massimo Caruso; Grazia Caci; Barbara Busà; Alfio Pennisi; Maurizio Ceracchi; Marcello Migliore; Maria Signorelli
• Keywords: Tolerability; Quitline; Clinical endpoint; Intention-to-treat analysis

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