ISRCTN61193406.

Study name	Do e‐cigarettes help smokers quit when not accompanied by intensive behavioral support? A multi‐center randomized controlled trial
Methods	RCT Setting: UK Multicenter. Participants will be recruited mainly from hospitals and GP practices across the UK by the Clinical Research Network. The study is being organized by Queen Mary University of London (QMUL) Researchers from QMUL will provide the study treatment and conduct follow‐up calls
Participants	1170 people who smoke tobacco cigarettes Inclusion criteria: Adult daily smokers who are motivated to stop smoking Must own a mobile phone and be willing to try either an online or texting treatment package, or both, or an e‐cigarette with or without telephone support. Be happy to receive follow‐up calls Be able to read/write/understand English Exclusion criteria: Women who are pregnant Currently using an e‐cigarette
Interventions	1. Control: NHS Quit Now program (QN) 2. E‐cigarette starter pack with no ongoing support (EC) 3. EC starter pack with helpline support (EC+) The study will aim to use a refillable EC that is similar to the type used in a previous EC trial (One Kit ‐ Innokin, UK Ecig Store), and one that is compliant with UK regulations, and not produced by a tobacco company
Outcomes	Follow‐up at 4 weeks, 6 months and 12 months. CO at 6 and 12 months Primary outcome measure: Sustained smoking cessation at 6 months post‐TQD. This is measured by asking participants if they have smoked since their TQD at the 6‐month follow‐up. To be counted as a 'quitter', participants must report smoking no more than 5 cigarettes since 2 weeks post‐TQD with no smoking in the previous week, validated by carbon monoxide (CO) reading of < 8 ppm. Participants lost to follow‐up will be counted as smokers Secondary outcome measures: Validated sustained abstinence rates measured by asking smoking status and taking a carbon‐monoxide reading at 12 months post‐TQD Validated sustained abstinence rates between 6 and 12 months, measured by asking smoking status and taking a carbon‐monoxide reading at 6 and 12 months Self‐reported 7‐day point‐prevalence abstinence, measured by asking smoking status in last 7 days at 4 weeks, 6 months and 12 months post‐TQD Cigarette consumption in non‐abstainers by vaping status, measured by questionnaire at four weeks, 6 and 12 months Frequency and severity of urges to smoke and withdrawal symptoms, measured by questionnaire at 4 weeks post‐TQD. Weight, measured by asking weight at 4 weeks, 6 months and 12 months post‐TQD Respiratory symptoms, measured by questionnaire, at 4 weeks, 6 months and 12 months post‐TQD Treatment adherence and ratings, measured by questionnaire at 4 weeks (and 6 and 12 months for EC arms) Adverse reactions to EC, measured by questionnaire at 4 weeks, 6 and 12 months post‐TQD Cost‐effectiveness of the interventions, measured by questionnaires at baseline, 6 and 12 months Smokers' and health‐care professionals views and opinions of the helpline, measured by one‐off qualitative interviews separate to the main trial.
Starting date	Overall trial start date: 01 September 2020 Trial end date: 31 May 2024 Not yet recruiting. Last edited 12 August 2020
Contact information	Dr Katie Myers Smith, katie.smith@qmul.ac.uk
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