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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
18/02/2025

Titles & IDs
Public title
Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation
Scientific title
The New Zealand Quit Vaping Trial: Combination Nicotine Replacement Therapy Versus Nicotine Reduction.
Secondary ID [1] 0 0
U1111-1298-1142
Universal Trial Number (UTN)
Trial acronym
EQUIT3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaping Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vape-free and tobacco-free: self-reported continuous abstinence from vaping at six-months post-end of treatment
Timepoint [1] 0 0
Six months post-end of treatment
Secondary outcome [1] 0 0
Age
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Gender
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Ethnicity (self-reported)
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Education
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Number of years of continuous vaping
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Age started vaping
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Previous quit attempts
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Number of serious quit attempts
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Longest time being vape-free in the last 12 months
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Methods used to stop vaping during the last serious attempt
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Vape type
Timepoint [11] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
Secondary outcome [12] 0 0
Use of a nicotine salt
Timepoint [12] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping
Secondary outcome [13] 0 0
Strength of nicotine used
Timepoint [13] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping nicotine
Secondary outcome [14] 0 0
Vape flavor
Timepoint [14] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment in those still vaping nicotine
Secondary outcome [15] 0 0
Frequency of vaping in the last seven days
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Frequency of vaping on the days they vaped in the last seven days (Baseline)
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Money spent on vaping in last 7 days
Timepoint [17] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
Secondary outcome [18] 0 0
Vaping of other substances
Timepoint [18] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
Secondary outcome [19] 0 0
Name of other substances vaped
Timepoint [19] 0 0
Baseline, eight weeks (i.e., end of treatment), then at one-, three-, and six-months post end of treatment
Secondary outcome [20] 0 0
Vaping dependence
Timepoint [20] 0 0
Baseline
Secondary outcome [21] 0 0
Motivation to quit vaping
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Self-rated chances of giving up vaping for good this time
Timepoint [22] 0 0
Baseline
Secondary outcome [23] 0 0
Live with people who smoke tobacco
Timepoint [23] 0 0
Baseline
Secondary outcome [24] 0 0
Lives with people who vape
Timepoint [24] 0 0
Baseline
Secondary outcome [25] 0 0
Smoking history
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
Frequency of smoking in those that smoked tobacco
Timepoint [26] 0 0
Baseline
Secondary outcome [27] 0 0
Age started smoking
Timepoint [27] 0 0
Baseline
Secondary outcome [28] 0 0
Number of years of continuous smoking
Timepoint [28] 0 0
Baseline and six-months post end of treatment
Secondary outcome [29] 0 0
Cannabis use
Timepoint [29] 0 0
Baseline and six-months post end of treatment
Secondary outcome [30] 0 0
Change from baseline in alcohol use
Timepoint [30] 0 0
Baseline and six-months post end of treatment
Secondary outcome [31] 0 0
Change from baseline in body mass index
Timepoint [31] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [32] 0 0
History of mental health concerns
Timepoint [32] 0 0
Baseline
Secondary outcome [33] 0 0
Current mental health concerns
Timepoint [33] 0 0
Baseline
Secondary outcome [34] 0 0
Change from baseline in severity of mental health concerns, in those participants with mental health concerns.
Timepoint [34] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [35] 0 0
Asthma
Timepoint [35] 0 0
Baseline
Secondary outcome [36] 0 0
Change from baseline in asthma severity, in those participants with asthma
Timepoint [36] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [37] 0 0
Chronic Obstructive Pulmonary Disease (COPD)
Timepoint [37] 0 0
Baseline
Secondary outcome [38] 0 0
Change from baseline in severity of COPD, in those participants with COPD.
Timepoint [38] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [39] 0 0
Chronic pain
Timepoint [39] 0 0
Baseline
Secondary outcome [40] 0 0
Change from baseline in severity of chronic pain, in those participants with chronic pain.
Timepoint [40] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [41] 0 0
Frequency of coughing
Timepoint [41] 0 0
Baseline
Secondary outcome [42] 0 0
Change from baseline in frequency of coughing
Timepoint [42] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [43] 0 0
Frequency of shortness of breath
Timepoint [43] 0 0
Baseline
Secondary outcome [44] 0 0
Change from baseline in frequency in shortness of breath
Timepoint [44] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [45] 0 0
Health-related quality of life (five domains)
Timepoint [45] 0 0
Baseline
Secondary outcome [46] 0 0
Health-related quality of life (five domains)
Timepoint [46] 0 0
Baseline, eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [47] 0 0
Change in signs and symptoms of nicotine withdrawal in participants
Timepoint [47] 0 0
Baseline, eight weeks (i.e., end of treatment), one-, three-, and six-months post end of treatment
Secondary outcome [48] 0 0
Change in urge to vape
Timepoint [48] 0 0
In last eight weeks (measured at end of treatment), and one-, three-, and six-months post end of treatment
Secondary outcome [49] 0 0
Vape-free and tobacco-free (self-reported continuous abstinence)
Timepoint [49] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [50] 0 0
Vape-free and tobacco-free (self-reported point prevalence abstinence)
Timepoint [50] 0 0
In last eight weeks (measured at end of treatment), and one-, three-, and six-months post end of treatment
Secondary outcome [51] 0 0
Vape-free (self-reported continuous abstinence)
Timepoint [51] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [52] 0 0
Vape-free (self-reported point prevalence abstinence)
Timepoint [52] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [53] 0 0
Nicotine-free (self-reported continuous abstinence)
Timepoint [53] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [54] 0 0
Nicotine-free (verified continuous abstinence)
Timepoint [54] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [55] 0 0
Nicotine-free (self-reported point prevalence abstinence)
Timepoint [55] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [56] 0 0
Vaping (even a single puff) post end of treatment
Timepoint [56] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [57] 0 0
Frequency of vaping in the last 7 days in those still vaping (post end of treatment)
Timepoint [57] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [58] 0 0
Return to daily vaping (post end of treatment)
Timepoint [58] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [59] 0 0
Average vaping sessions per day, in those that are vaping everyday
Timepoint [59] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [60] 0 0
Time to first lapse back to vaping
Timepoint [60] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [61] 0 0
Time to first relapse back to vaping
Timepoint [61] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [62] 0 0
Tobacco use in participants who have never smoked
Timepoint [62] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [63] 0 0
Frequency of smoking in participants who have never smoked (but have smoked tobacco since starting the trial)
Timepoint [63] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [64] 0 0
Cigarettes smoked each day in participants who have never smoked (but currently smoke tobacco daily)
Timepoint [64] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [65] 0 0
Cigarettes smoked per day (in participants who used to smoke, but have returned to smoking)
Timepoint [65] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [66] 0 0
Time to first lapse back to smoking (in participants who used to smoke)
Timepoint [66] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [67] 0 0
Time to first relapse back to smoking (in participants who used to smoke)
Timepoint [67] 0 0
One-, three-, and six-months post end of treatment
Secondary outcome [68] 0 0
Number of self-reported serious adverse events
Timepoint [68] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [69] 0 0
Continuation of product use
Timepoint [69] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [70] 0 0
Use other vaping cessation support
Timepoint [70] 0 0
Eight weeks (i.e., end of treatment)
Secondary outcome [71] 0 0
Participants recommendations regarding the allocated product
Timepoint [71] 0 0
Eight weeks (i.e., end of treatment)
Secondary outcome [72] 0 0
Acceptability of the allocated intervention
Timepoint [72] 0 0
Eight weeks (i.e., end of treatment)
Secondary outcome [73] 0 0
Marginal cost per quitter
Timepoint [73] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [74] 0 0
Treatment crossover
Timepoint [74] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [75] 0 0
Engagement with treatment
Timepoint [75] 0 0
Eight weeks (i.e., end of treatment), then one-, three-, and six-months post end of treatment
Secondary outcome [76] 0 0
Treatment use
Timepoint [76] 0 0
Eight weeks (i.e., end of treatment)

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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
774
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University College, London
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical University of South Carolina
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06832098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Walker, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Calder, PhD
Address 0 0
Country 0 0
Phone 0 0
+64 9 373 7599
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06832098