Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation

This research focuses on maximizing the chances of successfully quitting vaping. A large, pragmatic community-based clinical trial is planned in New Zealand to build on existing evidence from previous vaping and smoking cessation research undertaken by the study team. The effectiveness of combination nicotine replacement therapy (NRT) compared to nicotine tapering on vaping abstinence has not yet been investigated, but both provide an opportunity to increase success with vaping cessation, especially when combined with written behavioural support to further boost quit rates. The planned trial will test whether using combination NRT will help more New Zealanders to quit vaping long-term, compared with a vape nicotine tapering plan. Participants in both groups will also receive written vaping cessation behavioural support.

Aim: To evaluate the effectiveness, safety and acceptability of combination NRT plus behavioural support compared with vape nicotine tapering plus behavioural support, on six-month vaping abstinence. Trial Design: A single-blind, two-arm, pragmatic community-based randomised trial. Eligibility criteria: Eligible participants must live in New Zealand, vape nicotine at least weekly, used to smoke tobacco regularly but not in the past 6-months OR have never smoked tobacco, are aged ≥16 years, and have no contraindications to the study treatment. Participants must be motivated to quit-vaping in the next eight weeks, have access to the internet, and be able to provide consent. Participants must also have no treatment preference (i.e., they are happy to use whatever treatment they are allocated). Full details of inclusion and exclusion criteria are provided later in this trial registration. Recruitment: Participants will be recruited from throughout New Zealand, using multi-media advertising with targeted promotion to reach indigenous Māori, Pacific, low socio-economic groups, and people with disabilities, given their disproportionately higher prevalence of vaping. Advertisements will direct potential participants to a trial website where they can read the participant information sheet. A two step-consent process will be used. First, interested participants will be asked for on-line consent to complete an online screening questionnaire to determine their eligibility for the trial and verify their phone number. Second, eligible and interested participants will then provide online consent to enter the trial. Baseline information: Baseline data will then be collected via the online platform, and will include demographic data, body mass index, vaping history, vaping dependence, motivation to quit, signs and symptoms of nicotine withdrawal and urge to vape, smoking history, alcohol use, cannabis use, self-reported comorbidities, health-related quality of life, and concomitant medication. Full details on the baseline data are provided later in this trial registration. Once participants complete and submit the baseline form, they will be randomised to one of the two trial treatment groups and immediately notified of their allocated intervention. Randomization: Participants will be assigned a unique registration number allocated by a central computer, following details submitted via the website. Eligible participants will be randomised via computer (1:1 ratio) to one of two trial groups using stratified block randomisation (using varying block sizes), and stratified by ethnicity (Māori, non-Māori) and smoking status (never smoked, used to smoke). The randomisation sequence will be generated by the trial statistician, and centrally managed and concealed until the point of randomisation. Blinding: This is a single-blind trial as participants will be aware of the intervention to which they have been allocated, and data collection by the trial researc Покажи пълното описание...

Inclusion Criteria: * Live in New Zealand. * Vape nicotine at least weekly (one or more days out of the past seven days). * Used to smoke (i.e. they have smoked tobacco regularly but not at all in the past six months) or have never smoked (i.e., they have never been a regular user of smoked tobacco, defined as less than 100 cigarettes in their lifetime). * Are aged ≥16 years. * Are motivated to quit vaping in the next eight weeks. * Are able to provide consent. * Have access to the internet via a computer or smart phone. * Are a registered patient at a New Zealand medical facility. Exclusion Criteria: * They have another person in their household currently enrolled in the study. * They smoke tobacco currently or were a recent regular user of tobacco. * They are enrolled in another vaping cessation programme/trial. * They self-report having had a serious cardiovascular event, or hospitalisation for a cardiovascular complaint, in the previous four weeks (e.g. stroke, myocardial infarction, unstable angina, cardiac arrhythmia, coronary artery bypass graft and angioplasty). * They self-report uncontrolled hypertension. * They have a strong preference to use/not use NRT or nicotine tapering. * They are current users of smoking cessation pharmacotherapy (e.g. NRT, varenicline, cytisine, nortriptyline \[including if it is used for a different indication\], and amitriptyline \[as it converts to nortriptyline\]. * They are currently enrolled in another vaping cessation programme/trial.