Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Sep 12, 2022
Open Peer Review Period: Sep 12, 2022 - Sep 27, 2022
Date Accepted: Feb 4, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A randomized controlled trial Comparing Effectiveness, tolerability, and Acceptability of Heated Tobacco ProductS vs. refillable Electronic cigarettes For cIgaREttes substitution: CEASEFIRE study.
ABSTRACT
Background:
Electronic cigarettes (ECs) and heated tobacco products (HTPs)are increasingly used to quit smoking. We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs in smokers not intending to quit
Objective:
Compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4) and refillable ECs (JustFog Q16) in smokers not intending to quit. Cessation intervention included motivational counseling. The primary
Methods:
A 12-week randomized non-inferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4) and refillable ECs (JustFog Q16) in smokers not intending to quit. Cessation intervention included motivational counseling. The primary endpoint of the study was carbon monoxide confirmed continuous abstinence rate from week 4 to week 12 (CAR 4-12). Secondary endpoints included: continuous reduction rate from week 4 to week 12 (CRR 4-12), and 7-day point prevalence of smoking abstinence or reduction.
Results:
A total of 211 participants completed the study. High quit rates (CAR 4-12) of 39.1% and 30.8% were observed for IQOS-HTP and JustFog-EC, respectively. Between-group difference for CAR 4-12 was not significant (P = 0.2028). CRR 4-12 for IQOS-HTP and JustFog-EC were 46.4% and 39.3%, respectively; between-group difference was not significant (P = 0.2358). At week 12, 7-day point prevalence of smoking abstinence for IQOS-HTP and JustFog-EC were 40.2% and 41.1%, respectively. The most frequent adverse events were cough and reduced physical fitness. Appreciation was satisfactory for both study products.
Conclusions:
Switching to HTPs elicited marked reduction in cigarette consumption in smokers not intending to quit, which was comparable to refillable ECs. HTPs may be a useful addition to the arsenal of reduced risk alternatives for tobacco cigarettes and may contribute to smoking cessation. Clinical Trial: ClinicalTrials.gov ID: NCT03569748. Registered June 25, 2018. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts¼1&cx¼-jg9qo4.
Citation
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