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

Date of birth will be recorded to enable the age at baseline to be reported for each treatment group (presented as a mean, and associated standard deviation, or median and inter-quartile range).

Gender will be reported as counts and proportions of male, female, and gender diverse at baseline, for each treatment group.

Ethnicity will be reported as counts and proportions of Maori, Pacific or Other, for each treatment group.

Education level will be reported as counts and proportions of participants with "less than 12 years of attending school" or "12 or more years of attending school" or "prefer not to answer", for each treatment group.

Participants will be asked how many years they have been vaping continuously, with results presented as a mean with the associated standard deviation (or median and interquartile range) for each treatment group.

The age participants started vaping will be reported, with results presented as a mean and associated standard deviation for each treatment group, or median and interquartile range.

Participants will be asked if they have tried to quit vaping before (Yes/No), with data reported as counts and proportions for each treatment group.

[If outcome 8 is answered YES] Participants will be asked about the number of serious quit attempts they have made (i.e., 0, 1, 2, 3, 4, 5 or more), with data presented as counts and proportions for each treatment group. "Serious attempt" is defined as they decided they would try to make sure they never vaped again.

[If outcome 9 is answered 1 or more] Participants will be asked about how long (in days) they managed to stop vaping in the last 12 months. This question is a free text field. Data will be grouped and reported as counts and proportions for each treatment group.

[If outcome 9 is answered 1 or more] Participants will be asked what methods they used to stop vaping, during their most recent quit attempt. Methods will include: Nothing, Support from former and/or current vapers, Support from my friends and/or family, Support from my workplace, Support from Quitline or another smoking cessation service, I tried reducing the strength of the nicotine over time, Nicotine patches, Nicotine gum, Nicotine lozenges, Nicotine mouth spray, Champix (varenicline), Cytisine, an app (asked for app name), Prayer, Something else (free text option). Multiple options can be chosen. Results will be reported as counts and proportions for each treatment group.

Participants will be asked what type of vape they are currently using. Options are a disposable device; a rechargeable device with pods; a rechargeable device with a refillable tank; a modifiable device, Other (free text option). Data presented as counts and proportions for each treatment group.

Participants will be asked if they vape a nicotine salt. (Yes, No, Sometimes, Don't know), with data presented as counts and proportions for each treatment group.

Participants will be asked what nicotine strengths they currently use (0mg or 0.0%; 1-3mg or 0.1-0.3%; 4-12mg or 0.4-1.2%; 13-28.5mg or 1.3-2.85%; More than 28.5mg or 2.85%; There is nicotine in the vape, but I don't know the strength; Don't know), with data presented as counts and proportions for each treatment group. Multiple options are permitted.

Participants will be asked what flavors they currently vape (Mint/Menthol; Tobacco; Fruit; Combination such as mint + fruit; Other [free text]). Multiple options are permitted. Results will be presented as counts and proportions for each treatment group.

Participants will be asked how often they vaped in the last seven days, with answer options of: Everyday; Six of the 7 days; Five of the 7 days; Four of the 7 days; Three of the 7 days; Two of the seven days; and On one day only. Data will be presented as counts and proportions for each treatment group.

Participants will be asked how often they vaped, on the days they vaped in the last seven days (i.e., how many times they vaped on and off for 5 minutes or more). Free text field. Data will be grouped and presented as counts and proportions.

Participants will be asked about how much money they spend on vaping during the week (on average), with answer options of $0-10; $11-20; $21-30; $31-40; $41-50; more than $50. Counts and proportions will be presented for each treatment group.

Participants will be asked if they have vaped substances other than nicotine, reported as counts and percentages responding 'Yes' or 'No', for each treatment group.

[Asked of those who answer YES to outcome 19] Participants will be asked what other substances they have vaped. This is a free text field. Results will be grouped by substance and reported as counts and percentages for each treatment group.

Vaping dependence will be determined using the validated 4-item e-cigarette dependence scale, with each item scored using a Likert scale of 0 "never" to 4 "almost always". Higher scores indicate higher levels of dependence, with scores ranging from 0 to 16). Results will be presented as a mean (with the associated standard deviation) for each treatment group.

Motivation to quit vaping, measured using a five-point Likert Scale, where 1=not very motivated and 5=very motivated. Results will be presented as a mean with the associated standard deviation (or median and interquartile range) for each treatment group.

Self-rated chances of giving up vaping for good this time, measured using a five-point Likert Scale, where 1=extremely low and 5=extremely high. Results will be presented as a mean with the associated standard deviation (or median and interquartile range) for each treatment group.

Participants will be asked if they live with people who smoke (Yes; No; Sometimes). Results will be presented as counts and proportions for each treatment group.

Participants will be asked if they live with people who vape (Yes; No; Sometimes). Results will be presented as counts and proportions for each treatment group.

Participants will be asked if they have ever regularly smoked tobacco in cigarettes, roll-your-owns, cigars, cigarillos, pipes, and/or shisha or water pipe. Answer options include: I have never smoked tobacco; I used to smoke tobacco, but don't now. Data will be reported as counts and proportions for each treatment group.

[Asked of those who answered outcome 26 "I used to smoke tobacco, but don't now"]. Participants will be asked about how often they smoked, when they used to smoke. Answer options are: Everyday; not every day. Data will be reported as counts and proportions for each treatment group.

[Asked of those who answered outcome 26 "I used to smoke tobacco, but don't now"]. Participants will be asked at what age they started smoking, with results presented as a mean with the associated standard deviation (or median and interquartile range) for each treatment group.

[Asked of those who answered outcome 26 "I used to smoke tobacco, but don't now"]. Participants will be asked how many years they smoked continuously, with results presented as a mean with the associated standard deviation (or median and interquartile range) for each treatment group.

Participants will be asked how often they have used cannabis in the past six months (never, monthly or less, 2-4 times a month, 2-3 times a week, 4 or more times a week). This will be dichotomised to never used and have used cannabis in the past six months. Results will be presented as counts and proportions for each treatment group. Data will be reported as counts and proportions for each treatment group.

Alcohol use will be measured using the three item Alcohol Use Disorders Identification Test (AUDIT-C). Item 1 asks "How often have you had a drink containing alcohol?" Item 2 asks with options of: Never (score=0); Monthly or less (score=1); 2-4 times per month (score=2); 2-3 times per week (score=3); 4 or more times a week (score=4). Item 2 asks "How many drinks do you usually have if you are drinking" with options of: 1 or 2 (score=0); 3 or 4 (score=1); 5 or 6 (score=2); 7 to 9 (score=3); 10 or more (score=4). Item 3 asks "How often have you had six or more drinks on one occasion?" with options of: Never (score=0); Less than monthly (score=1); Monthly (score=2); Weekly (score=3); Daily or almost daily (score=4). A total score ranges from 0 to 12. Higher scores indicate greater risk of alcohol dependence. Results will be presented as a mean (with the associated standard deviation) by gender each treatment group.

Self-reported height (m) and weight (kg) will be measured at baseline and combined to determine baseline body mass index (kg/m2). Self-reported weight (kg) will be asked at baseline, end of treatment, then at one, three, and six-months post end of treatment. Body mass index will be calculated for each timepoint to determine change in body mass index from baseline in those participants that quit vaping at these timepoints, compared to those that did not quit vaping.

Participants will be asked if they have ever received medical treatment in the past for any mental health concerns: depression; schizophrenia or related disorder; anxiety; another mental health concern (free text), none of the above. Data will be reported as counts and proportions for each treatment group.

Participants will be asked if they are currently receiving medical treatment for any mental health concerns, with answer options of: depression; schizophrenia or related disorder; anxiety; another mental health concern (free text), none of the above. Data will be reported as counts and proportions for each treatment group.

Participants who report at baseline that they are currently receiving treatment for any mental health concerns will be asked at follow-up whether their mental health symptoms have been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. Data will be reported as counts and proportions for each treatment group.

Participants will be asked at baseline if they have asthma (self-reported: Yes/No). Data will be reported as counts and proportions for each treatment group.

Participants who report at baseline that they have asthma will be asked at all follow-up time-points whether their asthma has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. Data will be reported as counts and proportions for each treatment group.

Participants will be asked at baseline if have COPD (self-reported: Yes/No). Data will be reported as counts and proportions for each treatment group.

Participants who report that they do have COPD will be asked at all follow-up time points whether their COPD has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. Data will be reported as counts and proportions for each treatment group.

Participants will be asked at baseline if have chronic pain (self-reported: Yes/No). Data will be reported as counts and proportions for each treatment group.

Participants who report that they do have chronic pain at baseline will be asked at all follow-up points whether their chronic pain has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. Data will be reported as counts and proportions for each treatment group.

Self-reported frequency of coughing will be measured at baseline (How often do you cough in your normal everyday life)? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Data will be reported as counts and proportions for each treatment group.

Self-reported frequency of coughing will be measured at each follow-up time point (How often do you cough in your normal everyday life)? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Data will be reported as counts and proportions for each treatment group.

Self-reported frequency of shortness of breath will be measured at baseline (How often do you get short of breath? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Data will be reported as counts and proportions for each treatment group.

Self-reported frequency of shortness of breath will be re-assessed at all follow-up time points (How often do you get short of breath? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Data will be reported as counts and proportions for each treatment group.

Measured using the EQ-5D-5L - a standardized measure of health-related quality of life developed by the EuroQol Group. EQ-5D-5L is not an abbreviation. The EQ-5D-5L consists of five questions - each describe a different dimension of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems. moderate problems, severe problems, extreme problems (labelled 1-5). Answers will be valued (weighted to New Zealand population norms) and transformed into a utility score using a scoring algorithm and presented as a mean (with the associated standard deviation) for each treatment group.

Measured using the EQ-5D-5L - a standardized measure of health-related quality of life developed by the EuroQol Group. EQ-5D-5L is not an abbreviation. The EQ-5D-5L consists of five questions - each describe a different dimension of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems. moderate problems, severe problems, extreme problems (labelled 1-5). Answers will be valued (weighted to New Zealand population norms) and transformed into a utility score using a scoring algorithm and presented as a mean (with the associated standard deviation) for each treatment group.

Measured using the Mood and Physical Symptoms Scale (MPSS) which consists of 5-point ratings of depressed mood, irritability, restlessness, hunger and difficulty concentrating. The MPSS score is calculated by summing all 5 items (scored 1-5: not at all, slightly, moderately, very, extremely) and has a range of 5 to 25, where higher scores indicate greater nicotine withdrawal. Scores will be presented as a mean with the associated standard deviation, for each treatment group.

Measured using a 6-point rating of time spent with an urge to vape (scored 0-5: not at all, a little of the time, some of the time, a lot of the time, almost all of the time, all of the time), and the strength of these urges over the past week (scored 0-5: no urges, slight, moderate, strong, very strong, extremely strong). Participants who tick 'Not at all' for time spent with urges to vape, then skip to the next section of questions and don't answer the question on strength of urges. For these participants the strength of urges is set at 0, therefore, this question will then have values 0 to 5. The urge score is calculated by summing the two urges questions and has a range 0 to 10, where higher scores indicate greater urge to smoke. Scores will be presented as a mean with the associated standard deviation, for each treatment group

Defined as self-reported continuous abstinence from vaping since end of treatment (i.e., no more than five vaping sessions since end of treatment) and no tobacco use (i.e. not smoking more than five cigarettes and no use of any tobacco products since end of treatment) - but may or may not be using nicotine replacement therapy

Defined as self-reported 7-day point prevalence abstinence from vaping since end of treatment (i.e., no more than five vaping sessions in the last 7 days and no tobacco use in the last 7 days (not even a single puff/use), but may or may not be using nicotine replacement therapy.

Defined as self-reported continuous abstinence from vaping since end of treatment (i.e., no more than five vaping sessions since end of treatment) - but may or may not be using tobacco and/or nicotine replacement therapy.

Defined as self-reported 7-day point prevalence abstinence from vaping since end of treatment (i.e., no more than five vaping sessions in the last 7 days) - but may or may not be using tobacco and/or nicotine replacement therapy.

Defined as self-reported continuous abstinence from nicotine since end of treatment, i.e., not vaping nicotine (not vaping nicotine more than five vaping sessions since end of treatment), not using tobacco ((not smoking more than five cigarettes and no use of any other tobacco products since end of treatment), and not using any nicotine replacement therapy since end of treatment.

Verified six-month continuous abstinence from nicotine, defined as not vaping nicotine (not vaping nicotine more than five vaping sessions since end of treatment,), not using any tobacco products (not smoking more than five cigarettes and no use of any other tobacco products since end of treatment,), and not using any nicotine replacement therapy since the end of treatment. Abstinence will be verified using salivary cotinine (an established marker for nicotine from nicotine replacement therapy, vapes and tobacco) where a reading of ≤10 ng/ml signifies abstinence. Samples will be obtained from participants in the greater Auckland region who claim they are nicotine-free. sample results will be extrapolated to the full trial sample (Note: we do not have the funding to collect and test saliva samples from across all of New Zealand).

Defined as self-reported 7-day point prevalence abstinence from nicotine since end of treatment, i.e., not vaping nicotine in the last 7 days, not using tobacco in the last 7 days (not even a single puff/use), and not using nicotine replacement therapy in the last 7 days.

Participants will be asked if they have vape (even a single puff) since the last contact post end of treatment, with answer options of: none, Yes a few puffs; Yes, 1 vaping session; Yes, 2 vaping sessions; Yes, 3 vaping sessions; Yes, 4 vaping sessions; Yes, 5 vaping sessions; Yes, more than 5 vaping sessions. A vaping cessation is defined as vaping on and off for 5 minutes or more. Data will be presented as counts and proportions for each treatment group.

Participants will be asked how often they vaped in the last seven days, with answer options of: no, not even a puff; yes, a few puffs; Yes, between 1 and 5 vaping sessions, yes, more than 5 vaping sessions. Data will be presented as counts and proportions for each treatment group.

Participants will be asked if they have gone back to vaping daily (Yes or No). Data will be presented as counts and proportions for each treatment group.

[Those that respond Yes to Outcome 59]: Those that are vaping every day will be asked for the average number of vaping sessions per day [free text]. Data will be presented as means and standard deviations for each treatment group.

Defined as time to first use of a vape since end of treatment, even a single puff.

Defined as time to having more than 5 vaping sessions per day for 3 or more days in a row, since end of treatment.

Participants who have never smoked will be asked at each follow-up call whether they have smoked any tobacco since starting the trial (even just a puff). Answer options include: No, Yes - manufactured cigarettes, Yes - roll-your-own cigarettes, Yes- cigars, Yes - cigarillos, Yes - pipe, Yes - shisha / water pipe, Yes - other [free text field]. Multiple 'Yes' options can be chosen. Data will be reported as counts and proportions for each treatment group.

Asked of those who answered 'Yes' to outcome 63. Participants will be asked how often they have smoked tobacco since starting the trial. Answer options are: daily; not every day, Just once or twice. Data will be reported as counts and proportions for each treatment group

Asked of those who answered 'daily' to outcome 64. Participants will be asked about the number of cigarettes they smoke each day, with results presented as a mean (with the associated standard deviation) for each treatment group.

Number of cigarettes smoked per day, presented as summary statistics (mean, median, standard deviation, IQR)

Defined as time to first cigarette smoked since end of treatment, even a single puff.

Defined as time to smoking more than five cigarettes a day for three or more days in a row.

Only serious adverse events (SAEs) will be collected, given the well-known safety profile of NRT. Participants will be asked at each follow-up call about any new, unusual, unexpected serious adverse events during or since starting treatment, and whether they felt the event was related to treatment. SAEs will be classified as death, life threatening, hospitalization, persistent or sustained disability/incapacity, congenital abnormality/birth defect, or significant medical event. The likelihood of causality will be assessed using the World Health Organization Standardized Case Causality Assessment Tool (certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable). Data will be summarized as counts and percentages, according to treatment group.

Defined as continued use of the allocated treatment by participants after the end of the designed 8-week treatment period. Participants in the NRT group will also be asked if they used other forms of NRT, such as nicotine gum, lozenges, etc.

Participants will be asked about the use of other vaping cessation support, (i.e., support from former/current vapers; friends and/or family; work-place; Quitline or another smoking cessation service, own tapering plan; Nicotine patches; Nicotine gum; Nicotine lozenges; Nicotine mouth spray; Champix (varenicline); Cytisine; An app; Prayer; Complementary/alternative therapy or natural health product(s); Something else [free text]. Multiple answers options are permitted. Data will be reported as counts and proportions for each treatment group.

Participants will be asked if they would recommend the allocated treatment to another person who vaped and wanted to quit (Answer options of: Yes; No]. People allocated the NRT will also have the answer options of "recommend mouth spray only' and "recommend nicotine patch only'. Data will be reported as counts and proportions for each treatment group.

Participants will be asked for their views on the use of the allocated product(s) as a cessation aid, that is what participants liked or disliked about using the product(s): Answers will be provided as free text and summarized thematically.

If the nicotine replacement therapy treatment is superior to the tapering plan, a cost-effectiveness analysis will be undertaken.

Participants in the nicotine reduction group will be asked whether they accessed and used nicotine patches and/or mouth spray during the trial, and if so, at what time during the trial and what product and nicotine strength they used. Participants in the nicotine reduction group will also be asked if they used other forms of NRT, such as nicotine gum, lozenges, etc, during the trial, with results reported as the counts and proportion at each time period.

Participants will be asked about use of their allocated intervention. Engagement in the NRT group will be defined as use of their allocated interventions (patches and/or mouth spray) at least once during first two weeks (Yes/No). Engagement in the tapering group will be defined as reading and/or using the tapering plan at least once in the first two weeks (Yes/No).

Participants allocated nicotine replacement therapy will be asked to provide a count of how much of the provided NRT they still have at end of treatment. Both groups will be asked about use of their allocated intervention at least once in the last 8 weeks (during the intervention period).