Non-inferiority trial comparing cigarette consumption, adoption rates, acceptability, tolerability, and tobacco harm reduction potential in smokers switching to Heated Tobacco Products or electronic cigarettes: Study protocol for a randomized controlled trial

Abstract

Background: Despite the introduction of tobacco control measures, smoking remains highly prevalent in most EU countries. In Italy, one in four adults were still regular smokers in 2017. Increasing use of combustion-free delivering nicotine technologies for cigarette substitution may accelerate the current downward trends in smoking prevalence. Whether Heated Tobacco Products (HTPs) are more effective tobacco smoking substitutes that may potentially facilitate adoption and full conversion compared to e-cigarettes (ECs) is not known.We have designed a prospective study to compare changes in cigarette consumption and adoption rates among smokers randomized to either HTPs or ECs. Product acceptability, tolerability, and their tobacco harm reduction potential will be also compared.

Methods: 220 healthy smokers, not motivated to quit, will be randomized into a 12-weeks single-center, open label, non-inferiority trial comparing study outcomes from HTPs vs. ECs use. The primary outcome will be biochemically verified self-reported continuous abstinence at 12-weeks from the previous visit. Secondary outcomes will include: smoking reduction from baseline, adoption rates and product acceptability, tolerability, changes in step test values and in the level of selected biomarkers of exposure in exhaled breath (i.e. eCO) and in spot urine samples. A follow-up visit will be also included at 24-weeks to review product usage and smoking behavior under naturalistic condition of use.Recruitment of participants started in May 2019 and enrolment is expected to be completed in November 2019.

Discussion: This will be the first study directly comparing Heated Tobacco Products with Electronic Cigarettes in term of reduction in cigarette consumption, adoption rates, product acceptability, tolerability, and tobacco harm reduction potential. This knowledge can contribute to a better understanding of the potential role of this new technology in the evolving nicotine consumer market.

Trial registration: ClinicalTrials.gov ID: NCT03569748.Registered June 25, 2018.https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4.

Keywords: Acceptability; Effectiveness; Electronic cigarettes; Harm reduction; Heated tobacco products; IQOS; Just fog; Non-inferiority trial; Smoking; Tolerability.

Conflict of interest statement

EM, DS and RP are full-time employee of the University of Catania, Italy. PC, MC and RE are fixed-term researcher at University of Catania, Italy. MM is fixed-term researcher at Centro per la Prevenzione e Cura del Tabagismo, University of Catania. BB is full-time employee of ARNAS Garibaldi, Catania, Italy. AP is full-time employee of Casa di Cura Musumeci-Gecas, Gravina di Catania, Italy. UP is full-time employee of Ospedale “San Vincenzo” - Taormina, Italy. In relation to his work in the area of tobacco control, RP has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications. He has also received support from The Consumer Advocates for Smoke-free Alternatives (CASAA) for publication and open access costs of one paper. He has also served as a consultant for Pfizer, Global Health Alliance for treatment of tobacco dependence, ECITA (Electronic Cigarette Industry Trade Association, in the UK), Arbi Group Srl., and Health Diplomats (consulting company that delivers solutions to global health problems with special emphasis on harm minimization). Lectures fees from a number of European electronic cigarette industry and trade associations (including FIVAPE in France and FIESEL in Italy) were directly donated to vapers advocacy no-profit organizations. He is also currently involved in the following pro bono activities: scientific advisor for LIAF, Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League) and for The Consumer Advocates for Smoke-free Alternatives (CASAA); Chair of the European Technical Committee for standardization on “Requirements and test methods for emissions of electronic cigarettes” (CEN/TC 437; WG4). The other authors have no conflict of interests to declare.

© 2020 Published by Elsevier Inc.

Figures

Fig. 1

Schematic diagram of the study design (to be inserted).

Fig. 2

The IQOS devices (to be inserted).

Fig. 3

The Heets of the study (to be inserted).

Fig. 4

The JustFog devices (to be inserted).

Fig. 5

The e-liquids of the study (to be inserted).