Puff vs Pill: Break the Habit Study: Effect of Nicotine Vaping Products vs Varenicline on Smoking Cessation Among People Experiencing Social Disadvantage.

Nicotine vaping products (NVPs) in the form of two “pod” devices either prefilled [alt.] and refillable [VAPO Rift Pro] with nicotine salt e-liquids containing nicotine (4%;40mg/ml) in tobacco or mint flavours for 12 weeks. For each device a USB charger and wall adapter will be provided. Participants will be provided with detailed instructions on how to use the vaping products, along with a wallet card and fridge magnet with product use and safety information for quick access. Participants are advised to use the study product ad libitum throughout the day to either mitigate or satiate the urge to smoke tobacco products. They are encouraged to stop using the devices once they no longer feel the urge to smoke. The alt. device has replaceable pre-filled 2ml pods that contain 40mg/ml nicotine salt e-liquid in either tobacco or mint flavour. The VAPO Rift Pro device has a refillable 2ml pod and is supplied alongside 40mg/ml nicotine salt e-liquid (provided in 30ml bottles) in tobacco and mint flavours. NVPs will be delivered to participants in two mailed deliveries. Both deliveries will be sent by a central pharmacy directly to participants. The first delivery (“Initiation Pack”) will be provided after the baseline interview. Participants will receive both prefilled (alt.) and refillable (VAPO Rift Pro) devices in mint and tobacco flavours as part of the initiation packs, as well as nicotine liquid in two flavours (tobacco, and mint) for both. The second delivery (“Continuation Pack”) is optional, and will be available after the first check-in call, 2-4 weeks after baseline, up until the 12-month follow-up interview. Participants will have the choice of selecting either or both e-liquids, and in any combination of flavours, for the alt. and VAPO Rift Pro device respectively, plus 1 spare device. Participants who do not complete their first check-in call or are not using the study products at the time of the first check-in call, will receive a letter in place of the study products instructing them to call the study toll free number if they change their mind and wish to continue using the study products The ingredients for tobacco and mint e-liquids are the same for both the alt and VAPO Rift Pro device, and include tobacco and mint flavouring respectively, as well as glycerol, propylene glycol, and nicotine (as benzoate). Adherence will be monitored via two check-in calls, check-in call 1 and 2, occurring between 2-4 weeks and 8-10 weeks respectively. After participants have received both study packs, they will also receive an email explaining to them how they can access further supply of vaping products outside of the study. Follow ups will occur with the participant at 4 months and 12 months post-baseline. The former will be an online survey and the latter a telephone interview. They will measure participant’s adherence to the treatment and the additional behavioural support. Participants are also provided 12-week text message behavioural quit support with the option to opt-out at any stage if desired. As part of the text message support program, 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 s, 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 text program to promote engagement with the program. The text message program has been developed based on similar programs used in two prior smoking cessation studies (Trial Id: ACTRN12621000076875, n = 1058 and (Trial Id: ACTRN12622000820707, n = 1246). The development of the original program (Trial Id: ACTRN12621000076875) was informed by the World Health Organization’s (WHO) Be He@lthy, Be Mobile handbook (World Health Organization, 2015). This handbook outlines key considerations for implementing large-scale tobacco cessation messaging programs and guided the development of the text message support framework. An expert advisory group (clinical trialists, smoking cessation specialists and text messaging specialists) further refined the program and ensured both general quit support provision and also dedicated content was provided which was treatment-specific (i.e. text message support regarding use of allocated treatment group e.g. either nicotine replacement therapy of nicotine vaping products), The text program also provided support regarding strategies for managing nicotine withdrawal and side effects, study progress s, goal setting, relapse prevention, and motivational messages. This original program was then adapted for a subsequent trial of a more tailored and longer text message program intervention (Trial Id: ACTRN12622000820707) and the current study. In the current study, the program was adjusted to include varenicline-specific messages for this treatment arm, as well as adjusted program length/text frequency. These amendments were made through consultation with the Trial Steering Committee and a Community and Consumer Advisory Committee (CCAC) (comprising current/ex-smokers from previous studies). The Trial Steering Committee reviewed the messaging to maintain consistency across treatment groups and enhance participant comprehension. The Community and Consumer Advisory Committee provided valuable insights and feedback that helped refine language, optimize message timing, and ensure messages were practical and supportive. Final content was endorsed by all CCAC members. In summary, the current text message program is the result of iterative development, empirical testing, and extensive stakeholder consultation across multiple studies and advisory committees.