ACTRN12621000076875.

Study name	Vaporised nicotine products versus nicotine replacement therapy for tobacco smoking cessation among low‐socioeconomic status smokers: a randomised controlled trial
Methods	Design: RCT
Participants	Inclusion criteria: Participants can be included if they meet the following criteria: • willing to allow the research team and study clinician to access their data for quality assurance and to maintain the integrity of the trial • 18 years of age or older • receiving a government pension or allowance (proxy for low SES) • are a current daily smoker • interested in quitting smoking and using the study products • willing to make a quit attempt in the next 2 weeks • have a mobile phone that can receive text messages • available for follow‐up over a 7‐month period • agree to use the allocated study product and refrain from using another quit‐smoking medication whilst using the study products • willing to receive daily quit support text messages during the treatment period (with the option to opt out during the study) • speak English and can provide consent • willing to allow the research team to share the collected contact detail
Interventions	Vaporised nicotine product (VNP) devices (1 tank device and 1 pod device) for 8 weeks plus 5‐week Text Message behavioural quit Support (TMS) with the option to opt out at any stage if desired. Participants will receive a mix of quit‐smoking support text messages with content including information on how to use the study products; coping with nicotine withdrawal symptoms; study progress updates; and motivational ‘feel good’ messages. A mix of text, emojis and links to resources such as videos, websites and Graphics Interchange Format (GIF) images, will be used throughout the TMS programme to promote engagement with the programme. Each device will be charged using the provided USB charger and wall adaptor. A replacement battery and replacement coils (5 pieces per pack) will also be provided. The VNP tank device used is the Innokin Endura T18 Personal Vaporizer, which has a refillable 2.5 ml tank for the e‐liquid (18 mg/ml nicotine). 3 e‐liquid flavours will be provided: tobacco, menthol and a fruit flavour. The study will have 3 e‐liquid suppliers to guarantee ongoing supply throughout the study: Lumo Liquid in 10 ml bottles; VAPO e‐liquid in 30 ml bottles; and DashVapes e‐liquid in 30 ml bottles. All e‐liquids are 18 mg/ml in strength. Lumo Liquid ingredients are as follows (w/w): tobacco flavouring (1.19%), nicotine (1.60%), vegetable glycerine (24.56%), propylene glycol (73.24%); menthol flavouring (4.83%), nicotine (1.60%), vegetable glycerine (22.99%), propylene glycol (71.18%); strawberry flavouring (0.63%), nicotine (1.60%), vegetable glycerine (33.00%), propylene glycol (71.00%). VAPO e‐liquid additional flavour ingredients are as follows (w/w): tobacco flavouring (25.88%), nicotine (17.25%), vegetable glycerine (36.53%), propylene glycol (20.34)
Outcomes	PRIMARY OUTCOME: CO‐verified 6‐month continuous abstinence at 7‐month follow‐up. Continuous 6‐month abstinence will be defined as having remained quit for 6 months (having smoked no more than 5 cigarettes in that time), and a CO level of ≤ 5 ppm. Depending on the participant's indicated preference, the CO breath test will be self‐administered using an using a hand‐held iCO™ Smokerlyzer® (using provided instructions), or administered by a trained researcher using a hand‐held iCO™ Micro+™ Smokerlyzer® with a disposable, one‐use mouthpiece. Both devices are non‐invasive and require the participant to blow air into the device for 15 seconds to measure their CO level. An exhaled CO level of ≤ 5 ppm will be considered abstinent. The final follow‐up interview will occur 7‐months after the baseline interview completion date SECONDARY OUTCOME: Change in financial stress (assessed using Index of Financial Stress).
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