Health TrialsbyHealthPanel

Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation

ConditionVaping Cessation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Auckland, New Zealand

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicotine patches plus nicotine mouth spray

    Combination product

    Transdermal HABITROL® patches (21mg/24 hrs) plus NICORETTE® QUICKMIST mouth spray (1mg nicotine/spray dose)

  • Nicotine Tapering Plan

    Other intervention

    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.

Treatment groups

774 Participants
are divided into 2 treatment groups
Group A: Combination NRT plus written behavioral supportActive comparator 1 intervention
Group B: Nicotine Tapering Plan plus written behavioral supportActive comparator 1 intervention

Trial outcomes

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).

Time frame
Six months post-end of treatment

Secondary outcomes

1

Age

Date of birth will be recorded to enable the age at baseline to be reported for each treatment group (presented as a mean, and associated standard deviation, or median and inter-quartile range).

Time frame
Baseline
2

Gender

Gender will be reported as counts and proportions of male, female, and gender diverse at baseline, for each treatment group.

Time frame
Baseline
3

Ethnicity (self-reported)

Ethnicity will be reported as counts and proportions of Maori, Pacific or Other, for each treatment group.

Time frame
Baseline
4

Education

Education level will be reported as counts and proportions of participants with "less than 12 years of attending school" or "12 or more years of attending school" or "prefer not to answer", for each treatment group.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Auckland, New Zealand

Lead sponsor

University College, London

Collaborator

Medical University of South Carolina

Collaborator

Flinders University

Collaborator

Source ClinicalTrials.gov
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