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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05311085
Registration number
NCT05311085
Ethics application status
Date submitted
5/11/2021
Date registered
5/04/2022
Titles & IDs
Public title
Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation (Cess@Tion)
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Scientific title
Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation
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Secondary ID [1]
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21/323
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Universal Trial Number (UTN)
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Trial acronym
Cess@Tion
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cytisine
Treatment: Drugs - Nicotine delivered via an e-cigarette
Other interventions - Cytisine plus nicotine delivered via an e-cigarette
Active comparator: Monotherapy (Cytisine only) - 12 weeks of cytisine: Participants allocated cytisine will be instructed to follow the manufacturer's 25-day dosing regimen, then follow a maintenance dose of cytisine from day 26 to week 12. Participants will also receive six months of text-based smoking cessation support.
Active comparator: Monotherapy (Nicotine e-cigarette only) - 12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.
Active comparator: Combination therapy (Cytisine plus a nicotine e-cigarette) - 12 weeks of cytisine (as above) and 12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.
Treatment: Drugs: Cytisine
Standard dosing of:
* days 1-3: one tablet (1.5mg) every two hours through the waking day (six tablets/day)
* days 4-12: one tablet every 2.5 hours (five tablets/day). Quit smoking date is day five.
* days 13-16: one tablet every three hours (four tablets/day)
* days 17-20: one tablet every 4-5 hours (three tablets/day)
* days 21-25: one tablet every six hours (two tablets/day)
Followed by a maintenance dose of cystine from day 26 to week 12 (one tablet every six hours: two tablets/day)
Treatment: Drugs: Nicotine delivered via an e-cigarette
Pod device delivering nicotine. Nicotine strength: 30mg/ml (3%). Flavour: Tobacco
Other interventions: Cytisine plus nicotine delivered via an e-cigarette
Cytisine: Standard dosing of:
* days 1-3: one tablet (1.5mg) every two hours through the waking day (six tablets/day)
* days 4-12: one tablet every 2.5 hours (five tablets/day). Quit smoking date is day five.
* days 13-16: one tablet every three hours (four tablets/day)
* days 17-20: one tablet every 4-5 hours (three tablets/day)
* days 21-25: one tablet every six hours (two tablets/day)
Followed by a maintenance dose of cystine from day 26 to week 12 (one tablet every six hours: two tablets/day)
Nicotine e-cigarette: Pod device delivering nicotine. Nicotine strength: 30mg/ml (3%). Flavour: Tobacco
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Proportion of participants with verified continuous smoking abstinence
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Assessment method [1]
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Defined as self-report of smoking not more than five cigarettes from the Quit date (day 0) and confirmed by standardized exhaled carbon-monoxide (CO) measurement with a Bedfont Smokerlyzer, (=9 ppm signifying abstinence). Sensitivity analysis will be undertaken looking at different cut-offs for the CO measurement, given lack of consensus about the best reading to use.
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Timepoint [1]
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Six months post-quit date
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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, with the associated standard deviation)
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Timepoint [1]
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Assessed at 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 the proportion of male, female, and gender diverse at baseline, for each treatment group
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Timepoint [2]
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Assessed at 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 the proportion of Maori, Pacific or Other at baseline, for each treatment group.
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Timepoint [3]
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Assessed at 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 the proportion of participants with "less than 12 years of schooling" or "equal or more than 12 years of schooling" or "refuse to answer" at baseline, for each treatment group.
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Timepoint [4]
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Assessed at baseline
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Secondary outcome [5]
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Age started smoking
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Assessment method [5]
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The age participants started smoking will be reported, with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [5]
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Assessed at baseline
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Secondary outcome [6]
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Number of years of continuous smoking
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Assessment method [6]
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Participant's will be asked how many years they have been smoking continuously, with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [6]
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Assessed at baseline
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Secondary outcome [7]
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Type of cigarettes smoked
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Assessment method [7]
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Type of cigarettes smoked will be reported as the proportion smoking factory-made only, roll-your-own tobacco only or both at baseline, for each treatment group
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Timepoint [7]
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Assessed at baseline
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Secondary outcome [8]
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Number of cigarettes smoked per day
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Assessment method [8]
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The number of cigarettes smoked per day will be asked, with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [8]
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Assessed at baseline
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Secondary outcome [9]
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Mean pack size (Factory-made cigarettes)
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Assessment method [9]
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Participants who smoke factory-made cigarettes will be asked what pack size they normally purchase (e.g. Pack of 20) with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [9]
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Assessed at baseline
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Secondary outcome [10]
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Median pack size (Factory-made cigarettes)
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Assessment method [10]
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Participants who smoke factory-made cigarettes will be asked what pack size they normally purchase (e.g. Pack of 20), with results presented as a median (with the associated interquartile range) for each treatment group.
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Timepoint [10]
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Assessed at baseline
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Secondary outcome [11]
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Mean pouch size (Roll your-own tobacco)
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Assessment method [11]
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Participants who smoke roll your-own tobacco will be asked what pouch size they normally purchase (e.g. Pack of 20) with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [11]
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Assessed at baseline
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Secondary outcome [12]
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Median pouch size (Roll your-own tobacco)
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Assessment method [12]
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Participants who smoke roll your-own tobacco will be asked what pouch size they normally purchase (e.g. Pack of 20), with results presented as a median (with the associated interquartile range) for each treatment group.
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Timepoint [12]
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Assessed at baseline
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Secondary outcome [13]
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Time taken to smoke the contents of a pack or pouch
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Assessment method [13]
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Participants will be asked how many days it takes for them to smoke the contents of a pack or pouch, with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [13]
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Assessed at baseline
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Secondary outcome [14]
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Level of cigarette dependence
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Assessment method [14]
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The level of cigarette dependence will be determined using the Heaviness of Smoking Index (HSI), which is a two-item measure based on: 1) the number of cigarettes smoked per day (cpd), categorized as: 10 or fewer cpd = 0 points; 11-20 cpd = 1 point; 21-30 cpd = 2 points; 31 cpd or more = 3 points), and 2) the time to first cigarette of the day, categorized as: within 5 minutes = 3 points, 6-30 minutes = 2 points; 31-60 minutes = 1 point; More than 60 minutes = 0 points. The HSI total score is calculated by summing these two items and has a range of 0 to 6, where higher scores indicate greater dependence. The proportion of participants with low cigarette dependence (total scores: 0-2), moderate cigarette dependence (total scores:3-4) and high cigarette dependence (total scores: 5-6) will be reported for each treatment group.
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Timepoint [14]
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Assessed at baseline
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Secondary outcome [15]
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At least one quit attempt in the past 12 months
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Assessment method [15]
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The proportion of participants who report at least one quit attempt in the past 12 months, will be reported for each treatment group.
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Timepoint [15]
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Assessed at baseline
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Secondary outcome [16]
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Time quit, for last quit attempt
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Assessment method [16]
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Of those who report at least one quit attempt in the past 12 months, the longest time participants managed to stop smoking for (in days) will be reported, with results presented as a median (with the associated interquartile range) for each treatment group.
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Timepoint [16]
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Assessed at baseline
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Secondary outcome [17]
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Methods used in previous quit attempt
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Assessment method [17]
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Of those who report at least one quit attempt in the past 12 months, the proportion reporting use of particular methods they used will be summarized for each treatment group. Methods will include nicotine patches, nicotine gum, nicotine lozenges, nicotine mouth spray, zyban (buproprion), nortriptyline (norpress), varenicline (champix), Quitline, community-based smoking cessation services, nicotine e-cigarette (vape), nicotine-free e-cigarette (vape), nothing, and other (free text option).
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Timepoint [17]
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Assessed at baseline
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Secondary outcome [18]
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Reduction in the number of cigarettes smoked in the past 12 months
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Assessment method [18]
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The proportion of participants who have cut down on the number of cigarettes they smoked in the past 12 months will be reported as "Yes" or "No" for each treatment group.
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Timepoint [18]
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Assessed at baseline
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Secondary outcome [19]
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Motivation to quit
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Assessment method [19]
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Motivation to quit in the next two weeks will be measured using a five point Likert Scale (where 1=not very motivated and 5=very motivated), with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [19]
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Assessed at baseline
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Secondary outcome [20]
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Chances of giving up smoking
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Assessment method [20]
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Chances of giving up smoking for good this time, will be measured using a five point Likert Scale (where 1=extremely low and 5=extremely high), with results presented as a mean (with the associated standard deviation) for each treatment group.
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Timepoint [20]
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Assessed at baseline
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Secondary outcome [21]
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Living with other people who smoke tobacco
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Assessment method [21]
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The proportion of participants living with other people who smoke tobacco will be reported as "Yes", "No", or "Sometimes" for each treatment group
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Timepoint [21]
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Assessed at baseline
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Secondary outcome [22]
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Living with other people who use nicotine e-cigarettes (vapes)
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Assessment method [22]
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The proportion of participants living with other people who use nicotine e-cigarettes (vapes) will be reported as "Yes", "No", or "Sometimes" for each treatment group.
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Timepoint [22]
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Assessed at baseline
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Secondary outcome [23]
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Has close friends who use nicotine e-cigarettes (vapes)
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Assessment method [23]
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The proportion of participants living with close friends who use nicotine e-cigarettes (vapes) will be reported as "Yes" or "No" for each treatment group.
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Timepoint [23]
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Assessed at baseline
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Secondary outcome [24]
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Alcohol use
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Assessment method [24]
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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 in the past year" 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 in the past year?" 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) for male, female and gender diverse for each treatment group.
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Timepoint [24]
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0
Assessed at baseline
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Secondary outcome [25]
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Cannabis use
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Assessment method [25]
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Participants will be asked if they have used cannabis for recreational or non-medical purposes in the last 12 months, shown as the percentage reporting 'Yes' or 'No'.
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Timepoint [25]
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0
Assessed at baseline
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Secondary outcome [26]
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Self-reported continuous smoking abstinence
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Assessment method [26]
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Defined as the proportion of participants who self-report smoking not more than five cigarettes, reported by treatment group
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Timepoint [26]
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Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [27]
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Self-reported 7-day point prevalence smoking abstinence
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Assessment method [27]
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Defined as the proportion of participants who self-report having smoked no cigarettes (not even a puff) in the past seven days, reported by treatment group
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Timepoint [27]
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Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [28]
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Change from baseline in the number of cigarettes smoked per day (if smoking) by participants
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Assessment method [28]
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Number of cigarettes smoked per day (if smoking) by participants, presented as summary statistics (mean, median, standard deviation, IQR)
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Timepoint [28]
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Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [29]
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Reduction in smoking by participants
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Assessment method [29]
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Defined as reducing cigarette consumption by at least 25% in terms of numbers of cigarettes smoked per day
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Timepoint [29]
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Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [30]
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Time to first lapse back to smoking by participants
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Assessment method [30]
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Defined as time to first cigarette smoked from the quit date, even a single puff
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Timepoint [30]
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Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [31]
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Time to first relapse back to smoking by participants
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Assessment method [31]
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Defined as time to smoking more than five cigarettes a day for three or more days in a row.
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Timepoint [31]
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Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [32]
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Proportion of participants who use other smoking cessation methods
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Assessment method [32]
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Participants will be asked about the use of NRT and other nicotine products, and non-NRT methods of cessation such as Zyban (buproprion), clonidine, nortriptyline, varenicline, acupuncture, Quitline etc.
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Timepoint [32]
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Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [33]
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Health-related quality of life (five domains)
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Assessment method [33]
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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 [33]
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Assessed at baseline, three, six and 12 months post-quit date
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Secondary outcome [34]
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Health-related quality of life (self-rated health)
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Assessment method [34]
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The EQ-5D-5L also includes a visual analogue scale, where the respondent records their self-rated health on a 1-100 scale where the endpoints are labelled 'The best health you can imagine' (labelled 100) and 'The worst health you can imagine' (labelled 0). The EQ VAS score will be summarized using the mean (and the associated standard deviation) by treatment group.
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Timepoint [34]
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Assessed at baseline, three, six and 12 months post-quit date
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Secondary outcome [35]
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Participant compliance with cytisine use
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Assessment method [35]
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Defined as having taken =80% of the required number of tablets over the three-month intervention period.
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Timepoint [35]
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Measured at three months post quit date.
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Secondary outcome [36]
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Number of cytisine tablets taken by participants
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Assessment method [36]
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Based on number of pills remaining, to be reported for each cytisine treatment group (presented as a mean, with the associated standard deviation)
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Timepoint [36]
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Measured at one and three months post quit date.
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Secondary outcome [37]
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Daily use of the allocated treatment by participants
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Assessment method [37]
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Proportion of participants who are currently using the allocated treatment (Yes/No), reported by treatment group
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Timepoint [37]
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Measured at quit date (day 0), then at one month post quit date.
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Secondary outcome [38]
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Reasons for not using allocated treatment
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Assessment method [38]
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Proportion of participants who report any given reason for non-use of treatment, reported according to treatment group
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Timepoint [38]
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Measured at quit date (day 0), then at one month post quit date.
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Secondary outcome [39]
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Frequency of use of the e-cigarette, by participants allocated e-cigarettes
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Assessment method [39]
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Participants allocated e-cigarettes will be asked how often they currently vape, with answer options of: not at all; daily; every couple of days; at least weekly; or other (free text option). The proportion of participants answering each option will reported according to each treatment group that received e-cigarettes.
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Timepoint [39]
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Measured at three months post quit date.
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Secondary outcome [40]
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Number of nicotine pods used, by participants allocated e-cigarettes
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Assessment method [40]
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Based on number of pods remaining to be reported for each e-cigarette treatment group (presented as a mean, with the associated standard deviation)
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Timepoint [40]
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Measured at one and three months post quit date.
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Secondary outcome [41]
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Signs and symptoms of nicotine withdrawal in participants
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Assessment method [41]
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Measured using the Mood and Physical Symptoms Scale (MPSS) which consists 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 [41]
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0
Measured at baseline and at three months (end of treatment).
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Secondary outcome [42]
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0
Urge to smoke in participants
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Assessment method [42]
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Measured using a 6-point rating of time spent with an urge to smoke (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 smoke, 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 [42]
0
0
Measured at baseline and at three months (end of treatment).
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Secondary outcome [43]
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0
Treatment switching (crossover from cytisine-only to e-cigarette)
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Assessment method [43]
0
0
Participants allocated cytisine only, will be asked if they accessed and used an e-cigarette during the trial, with results reported as the proportion at each time period.
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Timepoint [43]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [44]
0
0
Treatment switching (crossover from cytisine-only to e-cigarette): nicotine content of e-cigarette
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Assessment method [44]
0
0
Participants allocated cytisine only, who accessed and used an e-cigarette during the trial will be asked if the device had nicotine in it or not, with results reported as proportions at each time period
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Timepoint [44]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [45]
0
0
Treatment switching (crossover from e-cigarette-only to cytisine)
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Assessment method [45]
0
0
Participants allocated e-cigarettes only will be asked whether they accessed and used cytisine during the trial, with results reported as proportions at each time period.
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Timepoint [45]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [46]
0
0
Treatment switching (crossover from e-cigarette-only to cytisine): source of cytisine
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Assessment method [46]
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0
Participants allocated e-cigarettes-only, who accessed (but were not allocated) cytisine, will be asked how they obtained the cytisine, with results reported as proportions for each stated option at each time period.
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Timepoint [46]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [47]
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0
Change in e-cigarette use
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Assessment method [47]
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0
Participants allocated to the e-cigarette groups will be asked whether they changed the type of e-cigarette device and/or the nicotine strength and/or flavour they used in the e-cigarettes provided. If they did, they will be asked when they did this, and what the device type, nicotine strength and/or flavour was.
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Timepoint [47]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [48]
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0
Dual use of treatment and tobacco by participants
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Assessment method [48]
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0
Defined as daily use of both the allocated treatment and continued daily smoking of cigarettes.
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Timepoint [48]
0
0
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [49]
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0
Continuation of product use by participants
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Assessment method [49]
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0
Defined as continued use of the allocated treatment by participants after the end of the designed three-month treatment period.
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Timepoint [49]
0
0
Measured at six (in all) and 12 months (in a subsample).
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Secondary outcome [50]
0
0
Acceptability of allocated product
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Assessment method [50]
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0
Participants will be asked for their views on the use of the allocated product as a cessation aid, that is what participants liked or disliked about using the product(s): Answers will be provided as free text.
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Timepoint [50]
0
0
Measured at three months post-quit date (end of treatment)
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Secondary outcome [51]
0
0
Participants recommendations regarding the allocated product
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Assessment method [51]
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0
Participants will be asked if they would recommend the allocated treatment to another person who smoked but wanted to quit.(answer options of: Yes; No; Did not use product).
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Timepoint [51]
0
0
Measured at three months post-quit date (end of treatment)
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Secondary outcome [52]
0
0
Number of participants with self-reported adverse events
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Assessment method [52]
0
0
Participants will be asked about any new, unusual, unexpected health events during or since starting treatment, and whether they felt they were related to treatment. Serious adverse events will be classified as non-serious or serious (death, life threatening, hospitalization, persistent or sustained disability/incapacity, congenital abnormality/birth defect, 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).
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Timepoint [52]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [53]
0
0
Number of self-reported adverse events
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Assessment method [53]
0
0
Participants will be asked about any new, unusual, unexpected health events during or since starting treatment, and whether they felt they were related to treatment. Serious adverse events will be classified as non-serious or serious (death, life threatening, hospitalization, persistent or sustained disability/incapacity, congenital abnormality/birth defect, 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).
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Timepoint [53]
0
0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [54]
0
0
Change from baseline in body mass index
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Assessment method [54]
0
0
Self-reported height (in cm) 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 three and six months to determine change in body mass index from baseline to three and six months in those participants that have quit smoking at these timepoints, compared to those that have not quit smoking.
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Timepoint [54]
0
0
Asked at three and six months post-quit date
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Secondary outcome [55]
0
0
Change from baseline in frequency of shortness of breath in participants
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Assessment method [55]
0
0
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). Self-reported frequency of shortness of breath will be re-assessed at follow-up using the same criteria to determine change in frequency of shortness of breath from baseline to three and six months post quit (and at 12 months post-quit date in a subsample).
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Timepoint [55]
0
0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [56]
0
0
Change from baseline in frequency of coughing in participants
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Assessment method [56]
0
0
Self-reported frequency of coughing will be measured at baseline (How often do you cough? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Self-reported frequency of coughing will be re-assessed at follow-up using the same criteria, to determine change in frequency of coughing from baseline to three and six months post quit (and at 12 months post-quit date in a subsample).
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Timepoint [56]
0
0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [57]
0
0
Change from baseline in asthma severity, in those participants with asthma
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Assessment method [57]
0
0
Participants will be asked at baseline if have have asthma (self-reported: Yes/No). Participants who report that they do have asthma will be asked at follow-up whether their asthma has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study.
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Timepoint [57]
0
0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [58]
0
0
Change from baseline in severity of chronic pain, in those participants with chronic pain.
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Assessment method [58]
0
0
Participants will be asked at baseline if have have chronic pain (self-reported: Yes/No). Participants who report that they do have chronic pain will be asked at follow-up whether their chronic pain has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study.
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Timepoint [58]
0
0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [59]
0
0
Change from baseline in severity of Chronic Obstructive Pulmonary Disease (COPD), in those participants with COPD.
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Assessment method [59]
0
0
Participants will be asked at baseline if have have COPD (self-reported: Yes/No). Participants who report that they do have COPD will be asked at follow-up whether their COPD has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study.
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Timepoint [59]
0
0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [60]
0
0
Change from baseline in severity of mental health concerns, in those participants with mental health concerns.
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Assessment method [60]
0
0
Participants will be asked at baseline if they are currently receiving treatment for any mental health concerns (self-reported: depression; schizophrenia or related disorder; anxiety; another mental health concern ). Participants who report 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.
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Timepoint [60]
0
0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [61]
0
0
Concomitant medication
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Assessment method [61]
0
0
Information about types of medication currently used
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Timepoint [61]
0
0
Assessed at baseline, quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
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Secondary outcome [62]
0
0
Mean number of text-based behavioral support messages received by participants
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Assessment method [62]
0
0
Number of text-based behavioral support messages received by participants during the six months, reported as a mean, with associated standard deviation
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Timepoint [62]
0
0
Assessed at six months
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Secondary outcome [63]
0
0
Median number of text-based behavioral support messages received by participants
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Assessment method [63]
0
0
Number of text-based behavioral support messages received by participants during the six months, reported as a median, with associated interquartile range
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Timepoint [63]
0
0
Assessed at six months
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Secondary outcome [64]
0
0
Marginal cost per quitter
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Assessment method [64]
0
0
If combination treatment is better than monotherapy, a cost-effectiveness analysis will be undertaken. The total number of cigarettes smoked between quit date (QD) and 6-month follow-up (FU) will be multiplied by the mean cigarette cost. The total number of cytisine tablets used by participants between QD and 6-month FU will be multiplied by the tablet cost. The total number of e-cigarette pods used by participants between QD and 6-month FU will be multiplied by the pod cost. The total cost will be the sum of the above. The cost-per-quitter will be the total cost by quit status (using self-reported continuous smoking abstinence). The incremental cost-effectiveness ratio will be the total cost and quitting status. The cost-per-person reducing their daily cigarette consumption will be assessed by crossing the total cost by a binary variable created for the reduction of at least 25% in the number of cigarettes smoked per day between QD and 6-month FU.
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Timepoint [64]
0
0
Assessed at six months
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Eligibility
Key inclusion criteria
* Daily smokers who live in New Zealand
* Aged =18 years
* Motivated to quit smoking within the next two weeks
* Able to provide consent
* Have daily access to a mobile telephone that can text
* Have access to the internet via a computer or smart phone
* Are willing to use cytisine or an e-cigarette or both products to help quit smoking
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Have another person in their household currently enrolled in the study
* Are pregnant/breastfeeding, or are women trying to become pregnant in the next three months
* Are currently using smoking cessation medication (including using e-cigarettes daily for the last month)
* Are enrolled in another cessation programme/trial
* Have a known hypersensitivity to cytisine or nicotine e-cigarettes
* Self-report moderate/severe renal impairment
* Are undergoing treatment for active/latent tuberculosis
* Have experienced a myocardial infarction, stroke, or severe angina within the previous two weeks
* Have uncontrolled high blood pressure (>150 mmHg systolic, >100 mmHg diastolic)
* Have a history of seizures / epilepsy
* Have a strong preference to use or not to use cytisine and/or e-cigarettes in their quit attempt.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
807
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
New Zealand
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State/province [1]
0
0
Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This research focuses on maximizing the benefits of proven smoking cessation interventions to support people who smoke to quit, as part of the strategy to help New Zealand become smoke-free. A large, pragmatic community-based clinical trial is planned which draws on 15 years of smoking cessation research undertaken by the study team. This research has shown that both cytisine and nicotine e-cigarettes are more effective than nicotine replacement therapy at helping people to quit smoking, and are more acceptable to users. New Zealand research has also shown that text-messages offering advice and support around quitting smoking are highly effective and acceptable. The planned trial will test whether using cytisine and nicotine e-cigarettes together will help more New Zealanders to quit smoking long-term, compared to using cytisine alone or nicotine e-cigarettes alone. Participants in all three groups will also receive smoking cessation text-messaging behavioral support.
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Trial website
https://clinicaltrials.gov/study/NCT05311085
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Natalie Walker, PhD
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Address
0
0
University of Auckland, New Zealand
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
This plan is currently being developed and will be made available soon.
Please note that at least 25% of trial participants are likely to be Indigenous Maori. In New Zealand "indigenous data sovereignty recognizes that Maori data should be subject to Maori governance. Maori data sovereignty supports tribal sovereignty and the realization of Maori and Iwi aspirations." Requests to access trial data provided by Maori participants will be reviewed and considered by the Maori Research Advisory Committee at the National Institute for Health Innovation, University of Auckland.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
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When will data be available (start and end dates)?
Data requests can be submitted starting nine months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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Available to whom?
Requests for access to individual participant data, or trial documents, will be considered where: 1) the request is from qualified researchers engaging in independent scientific research; 2) the proposed use aligns with public good purposes; 3) a research proposal and Statistical Analysis Plan are provided for review and approval; 4) the request does not conflict with other requests or planned use by members of the trial steering committee; and 5) the requestor is willing to sign a data access agreement. Please send all requests to the principal investigator.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT05311085/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05311085