Caponnetto 2020.

Study name	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
Methods	Design: RCT Study dates: May 2019 to May 2020 Recruitment: advertising on social networks, in local media, and through distribution of flyers at university campus Location: Catania, Italy Setting: ambulatory setting
Participants	Number randomised: 220 expected Characteristics: N/A Specialist population: aged ≥ 19 years Inclusion criteria Healthy Current smoker (≥ 10 cigarettes per day) Smoker for ≥ 1 year Aged ≥ 19 years No intention to quit smoking in next 30 days Exclusion criteria Used nicotine product other than cigarettes or smoking cessation medication in past 3 months Pregnant or breastfeeding
Interventions	Randomised (1:1 ratio) to use an electronic HTP or an electronic cigarette Heated tobacco arm Device heating method: electronic Device name: IQOS 2.4 Device manufacturer: PMI Other instructions and details: receive IQOS 2.4 and tobacco sticks of their choice, with 3 flavour options. No products given past 12 weeks' follow‐up point Behavioural support: trained and counselled on use of HTP. Reports offered to participants at 12 weeks' follow‐up to minimise risk of relapse to smoking Instructions for smoking cessation/switching: switch from smoking cigarettes to using HTP E‐cigarette arm Device name: Just Fog Starter Kit Device Manufacturer: JFT Co Other instructions and details: receive Just Fog Starter Kit and e‐liquid of their choice, with 3 flavour options. No products given past 12 weeks' follow‐up point Behavioural support: trained and counselled on use of e‐cigarette. Reports offered to participants at 12 weeks' follow‐up to minimise risk of relapse to smoking Instructions for smoking cessation/switching: switch from smoking cigarettes to using e‐cigarette
Outcomes	Follow‐up time points: 1, 2, 4, 8, 12, and 24 weeks Abstinence outcomes: carbon monoxide‐verified abstinence from tobacco smoking Safety outcomes: biomarkers of toxicant and carcinogen exposure; biomarkers of harm; adverse events; serious adverse events Prevalence/sales outcomes: N/A
Starting date	May 2019
Contact information	Name: Pasquale Caponnetto, PhD Email: p.caponnetto@unict.it
Notes	Funding source Tobacco industry funded: quote: "This research is supported by an Investigator‐Initiated Study award by Philip Morris Products SA (PMI.IIS.2016.006). The study protocol was written by EM who was also the principal investigator of the study. Philip Morris Products SA had no role in the design of the study protocol and will not have any role during its execution, analysis, data interpretation or writing of the manuscript". Author conflicts of interest Quote: "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".