Caponnetto 2021.

Study characteristics
Methods	Design: single‐arm pilot study Recruitment: Authors wrote to physicians, psychiatrists, and other health care providers to inform them about the study. Flyers were posted within and outside of the Smoking Cessation Center of Catania University (Centro per la Prevenzione e Cura del Tabagismo — CPCT), at the Policlinico Vittorio Emanuele. Participants were recruited from Catania outpatient psychiatric clinics by researchers of CPCT. Clinicians from outpatient psychiatric clinics identified suitable participants and drew their attention to the study flyers.  Setting: Catania, Italy Study start date: 2017. End date not stated. Recruitment September 2017 to October 2017
Participants	Total N: 40 (single‐arm) All participants: individuals with schizophrenia spectrum disorders who smoke cigarettes Inclusion criteria: Adults attending psychiatric outpatient clinics in Catania who smoked 20 or more cigarettes daily were included. Able to meet the criteria for a schizophrenia spectrum disorder diagnosis without evidence of current exacerbation of illness Exclusion criteria: Pregnancy, breastfeeding, myocardial infarction or angina pectoris within the past 3 months, current poorly controlled asthma or chronic obstructive pulmonary disease. Female 35%. Mean age 48.3 (SD 12.1). Mean CPD 28 (SD 9). Mean FTND 8.3 (SD 1.8). E‐cigarette use at baseline: 12 (30%) had used EC either regularly or had tried. Motivated to quit: No
Interventions	EC: pod JUUL pod e‐cigarette, PAX Labs, a closed pod e‐cigarette product. The pod contains 0.7 mL of e‐liquid and up to 5% nicotine by weight.  At the BL visit, participants were given a free e‐cigarette starter kit containing one JUUL device with a charger and 5% nicotine pods, Virginia tobacco flavour with instructions on how to charge, activate, and use the e‐cigarette. A 4‐week supply of pods equivalent to their current cigarette smoking behaviour, according to the manufacturer’s guidelines, was supplied to each participant (one pod for every packet of 20 cigarettes; mean 128, minimum 80, and maximum 200). Support: Eligible participants were invited to use a JUUL e‐cigarette for at least 12 weeks and were followed up prospectively for 24 weeks. Participants received a 4‐week supply of pods on three occasions, BL, week 4 (study visit 2), and week 8 (study visit 3). Participants were informed that the product was potentially less harmful than combustible cigarettes and could be used as a cigarette substitute as much as they liked. Limited behavioural support was provided as part of the intervention and included behaviour substitution of combustible cigarettes with e‐cigarettes and self‐monitoring of combustible cigarette consumption through the use of study diaries. Phone contact at week 2, 6 & 10. Participants attended a total of five study visits.
Outcomes	Baseline, week 4 (study visit 2), week 8 (study visit 3), 12 weeks. 24‐week FU. Cessation: CO Reduction: CPD AEs: dry cough, headache, throat irritation Other outcomes: vital signs (BP and HR), weight, and mental health, subjective effects (e.g. satisfied, no aversion), acceptability
Study funding	The e‐cigarettes used in the study were donated by the manufacturer, PAX Labs (on June 13, 2017 the company became known as JUUL Labs). Acknowledgements: The authors wish also to thank PAX Labs (on June 13, 2017 the company became known as JUUL Labs) for the free supplies of JUUL e‐cigarette kits and pods. At the time the research was conducted, JUUL Labs were not part owned by Altria, a tobacco company. PAX Labs agreed also to supply pods for a further 3 months after the end of the pilot to participants who expressed a wish to continue using as JUUL was not available in Italy when this study was conducted and not currently available at the 5% nicotine strength. No separate funding was secured for the study.  Altria Group (formerly Philip Morris Companies) acquired a 35% stake in JUUL Labs on December 20, 2018, but the study was completed before Altria invested in JUUL.
Author declarations	MM is fixed‐term researcher at Centro per la Prevenzione e Cura del Tabagismo, University of Catania. JD is full‐time employee of City University of New York (United States). JK is full‐time employee of Weill Medical College of Cornell University, New York (United States). RP is full‐time employee of the University of Catania, Italy. In relation to his work in the area of tobacco control and respiratory diseases, RP has received lecture fees and research funding from Pfizer, Inc., GlaxoSmithKline plc, CV Therapeutics, NeuroSearch A/S, Sandoz, MSD, Boehringer Ingelheim, Novartis, Duska Therapeutics, and Forest Laboratories. He has also served as a consultant for Pfizer, Inc., Global Health Alliance for treatment of tobacco dependence, CV Therapeutics, NeuroSearch A/S, Boehringer Ingelheim, Duska Therapeutics, Forest Laboratories, ECITA (Electronic Cigarette Industry Trade Association, in the United Kingdom), Health Diplomat (consulting company that delivers solutions to global health problems with special emphasis on harm minimization), and Pharmacielo. RP was awarded an Investigator‐Initiated Study award programme established by Philip Morris International in 2017, but subsequently resigned from the role of Principal Investigator in 2018, before the trial began. Lecture fees from a number of European EC industry and trade associations (including Fédération Interprofessionnelle de la VAPE in France and Federazione Italiana Esercenti Svapo Elettronico in Italy) were directly donated to vaper advocacy no‐profit organizations. RP is the Founder of the Center of Excellence for the acceleration of Harm Reduction at the University of Catania (CoEHAR), which has received a grant from Foundation for a Smoke Free World to develop and carry out eight research projects. RP 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 Chair of the European Technical Committee for standardization on Requirements and test methods for emissions of electronic cigarettes (CEN/TC 437; WG4). PC is paid by the University of Catania as an external part‐time researcher and adjunct professor of clinical, addiction, and general psychology. He has been affiliated to the CoEHAR since December 2019 in a pro bono role. He is coauthor of a protocol paper supported by an Investigator‐Initiated Study award programme established by Philip Morris International in 2017. The other authors have no conflict of interests to declare.
Notes	New to 2022 update.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Single‐arm, open‐label
Allocation concealment (selection bias)	High risk	Single‐arm, open‐label
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: 37 (92.5%) participants completed all study visits and attended their follow‐up visit.
Selective reporting (reporting bias)	Unclear risk	No detail