Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation
EQUIT3
The New Zealand Quit Vaping Trial: Combination Nicotine Replacement Therapy Versus Nicotine Reduction.
1 other identifier
interventional
774
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 18, 2025
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
April 3, 2025
March 1, 2025
2.1 years
February 4, 2025
March 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vape-free and tobacco-free: self-reported continuous abstinence from vaping at 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).
Six months post-end of treatment
Secondary Outcomes (76)
Age
Baseline
Gender
Baseline
Ethnicity (self-reported)
Baseline
Education
Baseline
Number of years of continuous vaping
Baseline
- +71 more secondary outcomes
Study Arms (2)
Combination NRT plus written behavioral support
ACTIVE COMPARATORParticipants 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.
Nicotine Tapering Plan plus written behavioral support
ACTIVE COMPARATORParticipants allocated the eight-week nicotine tapering plan will be advised to follow the instructions provided. Participants will also receive written behavioural support.
Interventions
Transdermal HABITROL® patches (21mg/24 hrs) plus NICORETTE® QUICKMIST mouth spray (1mg nicotine/spray dose)
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Auckland, New Zealandlead
- University College, Londoncollaborator
- Medical University of South Carolinacollaborator
- Flinders Universitycollaborator
Study Sites (1)
School of Population Health, Faculty of Medical and Health Sciences, University of Auckland
Auckland, 1142, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Laking, PhD, MBChB
University of Auckland, New Zealand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 18, 2025
Study Start
March 25, 2025
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
April 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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 Māori. In New Zealand "indigenous data sovereignty recognizes that Māori data should be subject to Māori governance. Māori data sovereignty supports tribal sovereignty and the realization of Māori and Iwi aspirations." Requests to access trial data provided by Māori participants will be reviewed and considered by Dr George Laking (an indigenous Māori member of the trial steering committee).