Participants
word of mouth, bipolar disorder, alcoholism, psychosis
DEL, RECRUITMENT
Exclusive EC users who were vaping daily and intending to quit vaping were screened for inclusion in this study.The specific eligibility criteria were:Inclusion criteria: (a) ≥ 18 years of age; (b) exclusive daily EC use for ≥ 12 months; (c) at least one serious quit vaping attempt (defined as complete abstinence for at least 24 h) in the past; (d) willingness to quit vaping, confirmed by a “YES” response to each of two questions “Do you plan to quit vaping within the next 30 days?” and “Do you wish to participate in a vaping cessation program?”; (e) self-reported reduction in vape consumption by at least 50% before committing to target quit date (TQD) (this instruction is given at screening).Exclusion criteria: (a) current diagnosis of mental illnesses including major depression, psychosis, or bipolar disorder that were diagnosed and treated by psychiatrists or clinical psychologists; (b) history of alcoholism or drug/chemical abuse within 12 months prior to screening; (c) known medical condition that, in the opinion of the investigators, would compromise subjects’ safety or participation; (d) currently pregnant or breast feeding or intending to become pregnant during the trial; (e) use of vaping products containing zero nicotine.Eligible subjects were recruited from local vape shops, databases of people who previously smoked who attended a local smoking cessation center (Centro per la Prevenzione e Cura del Tabagismo (CPCT), University of Catania) and stopped smoking by switching to ECs, databases of people who previously smoked who took part in CoEHAR (CoEHAR, University of Catania) sponsored tobacco harm reduction and switching studies, social networks, WhatsApp chat of undergraduates and postgraduates of the University of Catania, and word of mouth among relatives and friends of study participants. The flow diagram of subjects is shown in Fig. Study flow diagram of study participants
The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/GCP applicable regulatory principles. The local ethical review board of the Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele (part of the Hospital Trust of Università di Catania) reviewed and approved the study protocol (approval reference number: n.88/2016/PO, 11/07/2016). All participants provided written informed consent prior to participating in the trial. The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42. Due to the unexpected issue of poor recruitment of people who smoke and use ECs, a change in the protocol was deemed necessary. The protocol amendment was reviewed and approved to include single users intending to quit vaping and dual users intending to quit smoking (n. 91/20l8/EMPO, 15/10/2018); data from dual users will be analyzed and presented in a separate paper.