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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06832098
Registration number
NCT06832098
Ethics application status
Date submitted
4/02/2025
Date registered
18/02/2025
Date last updated
3/04/2025
Titles & IDs
Public title
Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation
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Scientific title
The New Zealand Quit Vaping Trial: Combination Nicotine Replacement Therapy Versus Nicotine Reduction.
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Secondary ID [1]
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U1111-1298-1142
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Universal Trial Number (UTN)
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Trial acronym
EQUIT3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vaping Cessation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nicotine patches plus nicotine mouth spray
Other interventions - Nicotine Tapering Plan
Active comparator: Combination NRT plus written behavioral support - Participants allocated eight weeks of combination NRT (21mg patch plus 1mg mouth spray) will be advised to start using the patches daily, with the mouth spray used to relieve any 'breakthrough' cravings. Advice on reducing use of both products over the eight-week period will also be provided, following the manufacturers guidelines when these products are used for smoking cessation. Participants will also receive written behavioural support.
Active comparator: Nicotine Tapering Plan plus written behavioral support - Participants allocated the eight-week nicotine tapering plan will be advised to follow the instructions provided. Participants will also receive written behavioural support.
Other interventions: Nicotine patches plus nicotine mouth spray
Transdermal HABITROL® patches (21mg/24 hrs) plus NICORETTE® QUICKMIST mouth spray (1mg nicotine/spray dose)
Other interventions: Nicotine Tapering Plan
Tapering plan based on their current e-juice nicotine concentration and frequency of vaping upon entry to the trial. Participants will use their own vapes and nicotine e-liquid.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Vape-free and tobacco-free: self-reported continuous abstinence from vaping at six-months post-end of treatment
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Assessment method [1]
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Self-report of no device use (defined as not more than five vaping sessions since end of treatment), and self-report of not smoking (defined as no use of any tobacco, but individuals may or may not be using NRT. The tobacco-free status will be verified using exhaled carbon-monoxide (CO) measurement with a Bedfont Smokerlyzer (=5 ppm signifying abstinence).
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Timepoint [1]
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Six months post-end of treatment
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Secondary outcome [1]
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Age
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Gender
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Assessment method [2]
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Gender will be reported as counts and proportions of male, female, and gender diverse at baseline, for each treatment group.
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Ethnicity (self-reported)
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Assessment method [3]
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Ethnicity will be reported as counts and proportions of Maori, Pacific or Other, for each treatment group.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Education
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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Number of years of continuous vaping
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Age started vaping
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Previous quit attempts
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline
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Secondary outcome [8]
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Number of serious quit attempts
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Assessment method [8]
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\[If outcome 8 is answered YES\] 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.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Longest time being vape-free in the last 12 months
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Assessment method [9]
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\[If outcome 9 is answered 1 or more\] 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.
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Methods used to stop vaping during the last serious attempt
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Assessment method [10]
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\[If outcome 9 is answered 1 or more\] 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.
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Timepoint [10]
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Baseline
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Secondary outcome [11]
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Vape type
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
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Secondary outcome [12]
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Use of a nicotine salt
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping
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Secondary outcome [13]
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Strength of nicotine used
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping nicotine
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Secondary outcome [14]
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Vape flavor
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping nicotine
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Secondary outcome [15]
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Frequency of vaping in the last seven days
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline
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Secondary outcome [16]
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Frequency of vaping on the days they vaped in the last seven days (Baseline)
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline
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Secondary outcome [17]
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Money spent on vaping in last 7 days
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
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Secondary outcome [18]
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Vaping of other substances
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
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Secondary outcome [19]
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Name of other substances vaped
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Assessment method [19]
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\[Asked of those who answer YES to outcome 19\] 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.
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Timepoint [19]
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Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
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Secondary outcome [20]
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Vaping dependence
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline
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Secondary outcome [21]
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Motivation to quit vaping
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline
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Secondary outcome [22]
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Self-rated chances of giving up vaping for good this time
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Assessment method [22]
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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.
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Timepoint [22]
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Baseline
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Secondary outcome [23]
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Live with people who smoke tobacco
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline
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Secondary outcome [24]
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Lives with people who vape
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Assessment method [24]
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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.
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Timepoint [24]
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Baseline
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Secondary outcome [25]
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Smoking history
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Assessment method [25]
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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.
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Timepoint [25]
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Baseline
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Secondary outcome [26]
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Frequency of smoking in those that smoked tobacco
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Assessment method [26]
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\[Asked of those who answered outcome 26 "I used to smoke tobacco, but don't now"\]. 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.
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Timepoint [26]
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Baseline
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Secondary outcome [27]
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Age started smoking
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Assessment method [27]
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\[Asked of those who answered outcome 26 "I used to smoke tobacco, but don't now"\]. 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.
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Timepoint [27]
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Baseline
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Secondary outcome [28]
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Number of years of continuous smoking
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Assessment method [28]
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\[Asked of those who answered outcome 26 "I used to smoke tobacco, but don't now"\]. 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.
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Timepoint [28]
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Baseline and six-months post end of treatment
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Secondary outcome [29]
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Cannabis use
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Assessment method [29]
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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.
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Timepoint [29]
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Baseline and six-months post end of treatment
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Secondary outcome [30]
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Change from baseline in alcohol use
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Assessment method [30]
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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.
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Timepoint [30]
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Baseline and six-months post end of treatment
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Secondary outcome [31]
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Change from baseline in body mass index
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Assessment method [31]
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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.
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Timepoint [31]
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Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [32]
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History of mental health concerns
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Assessment method [32]
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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.
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Timepoint [32]
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Baseline
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Secondary outcome [33]
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Current mental health concerns
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Assessment method [33]
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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.
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Timepoint [33]
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Baseline
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Secondary outcome [34]
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Change from baseline in severity of mental health concerns, in those participants with mental health concerns.
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Assessment method [34]
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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.
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Timepoint [34]
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Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [35]
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Asthma
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Assessment method [35]
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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.
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Timepoint [35]
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Baseline
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Secondary outcome [36]
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Change from baseline in asthma severity, in those participants with asthma
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Assessment method [36]
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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.
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Timepoint [36]
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Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [37]
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Chronic Obstructive Pulmonary Disease (COPD)
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Assessment method [37]
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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.
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Timepoint [37]
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Baseline
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Secondary outcome [38]
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Change from baseline in severity of COPD, in those participants with COPD.
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Assessment method [38]
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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.
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Timepoint [38]
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Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [39]
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Chronic pain
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Assessment method [39]
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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.
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Timepoint [39]
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Baseline
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Secondary outcome [40]
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Change from baseline in severity of chronic pain, in those participants with chronic pain.
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Assessment method [40]
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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.
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Timepoint [40]
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Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [41]
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Frequency of coughing
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Assessment method [41]
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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.
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Timepoint [41]
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Baseline
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Secondary outcome [42]
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Change from baseline in frequency of coughing
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Assessment method [42]
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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.
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Timepoint [42]
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Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [43]
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Frequency of shortness of breath
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Assessment method [43]
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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.
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Timepoint [43]
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Baseline
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Secondary outcome [44]
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Change from baseline in frequency in shortness of breath
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Assessment method [44]
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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.
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Timepoint [44]
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0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [45]
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Health-related quality of life (five domains)
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Assessment method [45]
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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.
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Timepoint [45]
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0
Baseline
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Secondary outcome [46]
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Health-related quality of life (five domains)
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Assessment method [46]
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0
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.
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Timepoint [46]
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0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [47]
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Change in signs and symptoms of nicotine withdrawal in participants
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Assessment method [47]
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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.
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Timepoint [47]
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0
Baseline, eight weeks (i.e., end of treatment), one-, three-, and six-months post end of treatment
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Secondary outcome [48]
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Change in urge to vape
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Assessment method [48]
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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
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Timepoint [48]
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In last eight weeks (measured at end of treatment), and one-, three-, and six-months post end of treatment
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Secondary outcome [49]
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Vape-free and tobacco-free (self-reported continuous abstinence)
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Assessment method [49]
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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
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Timepoint [49]
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Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
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Secondary outcome [50]
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Vape-free and tobacco-free (self-reported point prevalence abstinence)
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Assessment method [50]
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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.
Query!
Timepoint [50]
0
0
In last eight weeks (measured at end of treatment), and one-, three-, and six-months post end of treatment
Query!
Secondary outcome [51]
0
0
Vape-free (self-reported continuous abstinence)
Query!
Assessment method [51]
0
0
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.
Query!
Timepoint [51]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [52]
0
0
Vape-free (self-reported point prevalence abstinence)
Query!
Assessment method [52]
0
0
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.
Query!
Timepoint [52]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [53]
0
0
Nicotine-free (self-reported continuous abstinence)
Query!
Assessment method [53]
0
0
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.
Query!
Timepoint [53]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [54]
0
0
Nicotine-free (verified continuous abstinence)
Query!
Assessment method [54]
0
0
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).
Query!
Timepoint [54]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [55]
0
0
Nicotine-free (self-reported point prevalence abstinence)
Query!
Assessment method [55]
0
0
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.
Query!
Timepoint [55]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [56]
0
0
Vaping (even a single puff) post end of treatment
Query!
Assessment method [56]
0
0
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.
Query!
Timepoint [56]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [57]
0
0
Frequency of vaping in the last 7 days in those still vaping (post end of treatment)
Query!
Assessment method [57]
0
0
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.
Query!
Timepoint [57]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [58]
0
0
Return to daily vaping (post end of treatment)
Query!
Assessment method [58]
0
0
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.
Query!
Timepoint [58]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [59]
0
0
Average vaping sessions per day, in those that are vaping everyday
Query!
Assessment method [59]
0
0
\[Those that respond Yes to Outcome 59\]: 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.
Query!
Timepoint [59]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [60]
0
0
Time to first lapse back to vaping
Query!
Assessment method [60]
0
0
Defined as time to first use of a vape since end of treatment, even a single puff.
Query!
Timepoint [60]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [61]
0
0
Time to first relapse back to vaping
Query!
Assessment method [61]
0
0
Defined as time to having more than 5 vaping sessions per day for 3 or more days in a row, since end of treatment.
Query!
Timepoint [61]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [62]
0
0
Tobacco use in participants who have never smoked
Query!
Assessment method [62]
0
0
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.
Query!
Timepoint [62]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [63]
0
0
Frequency of smoking in participants who have never smoked (but have smoked tobacco since starting the trial)
Query!
Assessment method [63]
0
0
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
Query!
Timepoint [63]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [64]
0
0
Cigarettes smoked each day in participants who have never smoked (but currently smoke tobacco daily)
Query!
Assessment method [64]
0
0
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.
Query!
Timepoint [64]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [65]
0
0
Cigarettes smoked per day (in participants who used to smoke, but have returned to smoking)
Query!
Assessment method [65]
0
0
Number of cigarettes smoked per day, presented as summary statistics (mean, median, standard deviation, IQR)
Query!
Timepoint [65]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [66]
0
0
Time to first lapse back to smoking (in participants who used to smoke)
Query!
Assessment method [66]
0
0
Defined as time to first cigarette smoked since end of treatment, even a single puff.
Query!
Timepoint [66]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [67]
0
0
Time to first relapse back to smoking (in participants who used to smoke)
Query!
Assessment method [67]
0
0
Defined as time to smoking more than five cigarettes a day for three or more days in a row.
Query!
Timepoint [67]
0
0
One-, three-, and six-months post end of treatment
Query!
Secondary outcome [68]
0
0
Number of self-reported serious adverse events
Query!
Assessment method [68]
0
0
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.
Query!
Timepoint [68]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [69]
0
0
Continuation of product use
Query!
Assessment method [69]
0
0
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.
Query!
Timepoint [69]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [70]
0
0
Use other vaping cessation support
Query!
Assessment method [70]
0
0
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.
Query!
Timepoint [70]
0
0
Eight weeks (i.e., end of treatment)
Query!
Secondary outcome [71]
0
0
Participants recommendations regarding the allocated product
Query!
Assessment method [71]
0
0
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.
Query!
Timepoint [71]
0
0
Eight weeks (i.e., end of treatment)
Query!
Secondary outcome [72]
0
0
Acceptability of the allocated intervention
Query!
Assessment method [72]
0
0
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.
Query!
Timepoint [72]
0
0
Eight weeks (i.e., end of treatment)
Query!
Secondary outcome [73]
0
0
Marginal cost per quitter
Query!
Assessment method [73]
0
0
If the nicotine replacement therapy treatment is superior to the tapering plan, a cost-effectiveness analysis will be undertaken.
Query!
Timepoint [73]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [74]
0
0
Treatment crossover
Query!
Assessment method [74]
0
0
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.
Query!
Timepoint [74]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [75]
0
0
Engagement with treatment
Query!
Assessment method [75]
0
0
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).
Query!
Timepoint [75]
0
0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Query!
Secondary outcome [76]
0
0
Treatment use
Query!
Assessment method [76]
0
0
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).
Query!
Timepoint [76]
0
0
Eight weeks (i.e., end of treatment)
Query!
Eligibility
Key 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.
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/03/2025
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/04/2027
Query!
Actual
Query!
Sample size
Target
774
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Auckland, New Zealand
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
University College, London
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Medical University of South Carolina
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Flinders University
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06832098
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
George Laking, PhD, MBChB
Query!
Address
0
0
University of Auckland, New Zealand
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Amanda Calder, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+64 9 373 7599
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/98/NCT06832098/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06832098
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