None listed
Conditions
Brief summary
This is a parallel, single-blinded, randomised clinical trial evaluating the effectiveness, cost-effectiveness and safety of 8 weeks of treatment with a vaporised nicotine product (VNP) and nicotine liquid/pods compared to traditional oral nicotine replacement therapy (NRT; gum or lozenge) for smoking cessation among low-socioeconomic smokers. We hypothesize a higher 6-month cessation rate among the VNP, compared with the NRT group.
Interventions
Vaporised nicotine product (VNP) devices (one tank device and one 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 video
Vaporised nicotine product (VNP) devices (one tank device and one 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 program to promote engagement with the program. 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 2.5ml tank for the e-liquid (18mg/ml nicotine). Three e-liquid flavours will be provided: tobacco, menthol and a fruit flavour. The study will have three e-liquid suppliers to guarantee ongoing supply throughout the study: Lumo Liquid in 10ml bottles; VAPO e-liquid in 30ml bottles; and DashVapes e-liquid in 30ml bottles. All e-liquids are 18mg/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); menthol flavouring (21.03%), nicotine (17.25%), vegetable glycerine (41.85%), propylene glycol (20.09%); berry flavouring (27.50%), nicotine (17.25%), vegetable glycerine (39.42%), propylene glycol (15.83%). DashVapes e-liquid additional flavour ingredients are as follows (v/v): tobacco flavouring (10.00%), nicotine (1.80%), propylene glycol (40.00%), vegetable glycerine (48.20%); menthol flavouring (10.00%), nicotine (1.80%), propylene glycol (40.00%), vegetable glycerine (48.20%); and strawberry flavouring (10.00%), nicotine (1.80%), propylene glycol (40.00%), vegetable glycerine (48.20%); The VNP pod device is the Alt. Pod personal vaporiser. The pod device uses nicotine salt pods (4%; 40mg/mL). Alt. Pod ingredients are as follows (w/v): tobacco flavour (12%), nicotine (4%), benzoate (4%), propylene glycol (30%), vegetable glycerine (50%); menthol flavour (15%), nicotine (4%), benzoate (4%), propylene glycol (27%), vegetable glycerine (50%); mango flavour (20%), nicotine (4%), benzoate (4%), propylene glycol (17%), vegetable glycerine (55%). Participants are asked to use the study product ad libitum throughout the day and encouraged to stop smoking completely, or reduce smoking if unable to stop completely. Participants will be provided with detailed instructions on how to use the VNP devices effectively. The e-liquid will be provided in dropper bottles with childproof caps. Adherence will be monitored via two check-in calls in the first four weeks of the treatment period. These check in calls will also assess smoking status, treatment adherence, adverse events (AEs) or serious adverse events (SAEs), and any changes to concomitant medication at these time points.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 two 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 details for the purpose(s) of (i) the study doctor to make contact if required, (ii) the Social Research Centre to conduct two telephone interviews, and (iii) research staff from UNSW or a third-party contracted research organisation mailing out the study products; • willing for the study clinician to call if they need more information about health status and to inform the UNSW research team of their decision; • willing to complete two telephone check-in calls with the UNSW research team; and • willing to complete baseline and follow-up telephone interviews with the SRC.
Exclusion criteria
Participants will be excluded if they are: • currently participating in another quit smoking program or study; • currently using any quit smoking medications or products (i.e. NRT, bupropion [Zyban], varenicline [Champix], clonidine, nortriptyline, cytisine, vaporised nicotine product/electronic or e-cigarettes/inhalers or other quit smoking medication or product); • diagnosed with unstable angina (i.e. chest pain that occurs suddenly and becomes worse over time, which happens seemingly without cause, where patient may be resting or asleep); • hospitalised for stroke, heart attack, or another heart-related condition in the last two weeks; • women who are pregnant, breastfeeding or planning to become pregnant in the next 7 months; and • deemed medically unfit, by the study clinician, to participate at the time of screening (see below).
Outcome results
None listed