NCT06832098RecruitingPhase 3
The New Zealand Quit Vaping Trial: Combination Nicotine Replacement Therapy Versus Nicotine Reduction.
University of Auckland, New Zealand1 site in 1 country774 target enrollmentStarted: March 25, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 774
- Locations
- 1
- Primary Endpoint
- Vape-free and tobacco-free: self-reported continuous abstinence from vaping at six-months post-end of treatment
Study Overview
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.
Detailed Description
Aim:
To evaluate the effectiveness, safety and acceptability of combination NRT plus behavioural support compared with vape nicotine tapering plus behavioural support, on six-month vaping abstinence.
Trial Design:
A single-blind, two-arm, pragmatic community-based randomised trial.
Eligibility criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Live in New Zealand.
- •Vape nicotine at least weekly (one or more days out of the past seven days).
- •Used to smoke (i.e. they have smoked tobacco regularly but not at all in the past six months) or have never smoked (i.e., they have never been a regular user of smoked tobacco, defined as less than 100 cigarettes in their lifetime).
- •Are aged ≥16 years.
- •Are motivated to quit vaping in the next eight weeks.
- •Are able to provide consent.
- •Have access to the internet via a computer or smart phone.
- •Are a registered patient at a New Zealand medical facility.
Exclusion Criteria
- •They have another person in their household currently enrolled in the study.
- •They smoke tobacco currently or were a recent regular user of tobacco.
- •They are enrolled in another vaping cessation programme/trial.
- •They self-report having had a serious cardiovascular event, or hospitalisation for a cardiovascular complaint, in the previous four weeks (e.g. stroke, myocardial infarction, unstable angina, cardiac arrhythmia, coronary artery bypass graft and angioplasty).
- •They self-report uncontrolled hypertension.
- •They have a strong preference to use/not use NRT or nicotine tapering.
- •They are current users of smoking cessation pharmacotherapy (e.g. NRT, varenicline, cytisine, nortriptyline [including if it is used for a different indication], and amitriptyline [as it converts to nortriptyline].
- •They are currently enrolled in another vaping cessation programme/trial.
Arms & Interventions
Combination NRT plus written behavioral support
Active Comparator
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.
Intervention: Nicotine patches plus nicotine mouth spray (Combination Product)
Nicotine Tapering Plan plus written behavioral support
Active Comparator
Participants allocated the eight-week nicotine tapering plan will be advised to follow the instructions provided. Participants will also receive written behavioural support.
Intervention: Nicotine Tapering Plan (Other)
Outcomes
Primary Outcomes
Vape-free and tobacco-free: self-reported continuous abstinence from vaping at six-months post-end of treatment
Time Frame: Six months post-end of treatment
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).
Secondary Outcomes
- Treatment crossover(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Engagement with treatment(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Treatment use(Eight weeks (i.e., end of treatment))
- Age(Baseline)
- Gender(Baseline)
- Ethnicity (self-reported)(Baseline)
- Education(Baseline)
- Number of years of continuous vaping(Baseline)
- Age started vaping(Baseline)
- Previous quit attempts(Baseline)
- Number of serious quit attempts(Baseline)
- Longest time being vape-free in the last 12 months(Baseline)
- Methods used to stop vaping during the last serious attempt(Baseline)
- Vape type(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment)
- Use of a nicotine salt(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping)
- Strength of nicotine used(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping nicotine)
- Vape flavor(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping nicotine)
- Frequency of vaping in the last seven days(Baseline)
- Frequency of vaping on the days they vaped in the last seven days (Baseline)(Baseline)
- Money spent on vaping in last 7 days(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment)
- Vaping of other substances(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment)
- Name of other substances vaped(Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment)
- Vaping dependence(Baseline)
- Motivation to quit vaping(Baseline)
- Self-rated chances of giving up vaping for good this time(Baseline)
- Live with people who smoke tobacco(Baseline)
- Lives with people who vape(Baseline)
- Smoking history(Baseline)
- Frequency of smoking in those that smoked tobacco(Baseline)
- Age started smoking(Baseline)
- Number of years of continuous smoking(Baseline and six-months post end of treatment)
- Cannabis use(Baseline and six-months post end of treatment)
- Change from baseline in alcohol use(Baseline and six-months post end of treatment)
- Change from baseline in body mass index(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- History of mental health concerns(Baseline)
- Current mental health concerns(Baseline)
- Change from baseline in severity of mental health concerns, in those participants with mental health concerns.(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Asthma(Baseline)
- Change from baseline in asthma severity, in those participants with asthma(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Chronic Obstructive Pulmonary Disease (COPD)(Baseline)
- Change from baseline in severity of COPD, in those participants with COPD.(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Chronic pain(Baseline)
- Change from baseline in severity of chronic pain, in those participants with chronic pain.(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Frequency of coughing(Baseline)
- Change from baseline in frequency of coughing(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Frequency of shortness of breath(Baseline)
- Change from baseline in frequency in shortness of breath(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Health-related quality of life (five domains)(Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Change in signs and symptoms of nicotine withdrawal in participants(Baseline, eight weeks (i.e., end of treatment), one-, three-, and six-months post end of treatment)
- Change in urge to vape(In last eight weeks (measured at end of treatment), and one-, three-, and six-months post end of treatment)
- Vape-free and tobacco-free (self-reported continuous abstinence)(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Vape-free and tobacco-free (self-reported point prevalence abstinence)(In last eight weeks (measured at end of treatment), and one-, three-, and six-months post end of treatment)
- Vape-free (self-reported continuous abstinence)(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Vape-free (self-reported point prevalence abstinence)(One-, three-, and six-months post end of treatment)
- Nicotine-free (self-reported continuous abstinence)(One-, three-, and six-months post end of treatment)
- Nicotine-free (verified continuous abstinence)(One-, three-, and six-months post end of treatment)
- Nicotine-free (self-reported point prevalence abstinence)(One-, three-, and six-months post end of treatment)
- Vaping (even a single puff) post end of treatment(One-, three-, and six-months post end of treatment)
- Frequency of vaping in the last 7 days in those still vaping (post end of treatment)(One-, three-, and six-months post end of treatment)
- Return to daily vaping (post end of treatment)(One-, three-, and six-months post end of treatment)
- Average vaping sessions per day, in those that are vaping everyday(One-, three-, and six-months post end of treatment)
- Time to first lapse back to vaping(One-, three-, and six-months post end of treatment)
- Time to first relapse back to vaping(One-, three-, and six-months post end of treatment)
- Tobacco use in participants who have never smoked(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Frequency of smoking in participants who have never smoked (but have smoked tobacco since starting the trial)(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Cigarettes smoked each day in participants who have never smoked (but currently smoke tobacco daily)(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Cigarettes smoked per day (in participants who used to smoke, but have returned to smoking)(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Time to first lapse back to smoking (in participants who used to smoke)(One-, three-, and six-months post end of treatment)
- Time to first relapse back to smoking (in participants who used to smoke)(One-, three-, and six-months post end of treatment)
- Number of self-reported serious adverse events(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Continuation of product use(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Use other vaping cessation support(Eight weeks (i.e., end of treatment))
- Participants recommendations regarding the allocated product(Eight weeks (i.e., end of treatment))
- Acceptability of the allocated intervention(Eight weeks (i.e., end of treatment))
- Marginal cost per quitter(Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment)
- Health-related quality of life (five domains)(Baseline)
Investigators
George Laking
Associate Professor
University of Auckland, New Zealand
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
In Vivo Experience With NRT to Increase Adherence and Smoking AbstinenceSmoking Reduction or AbstinenceNCT02938403University of Alabama at Birmingham517
Completed
Phase 3
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and GenotypeSmoking CessationNCT00894166Duke University606
Completed
Not Applicable
Offering Proactive Tobacco TreatmentTobacco Use CessationNCT01123967University of Minnesota2,500
Completed
Phase 2
Innovative Interventions for Smoking CessationTobacco Use DisorderNCT01050569University of Minnesota235
Completed
Phase 3
The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking CessationSmoking CessationNCT02521662University of Auckland, New Zealand1,124