RecruitingPhase 3NCT06832098

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

The New Zealand Quit Vaping Trial: Combination Nicotine Replacement Therapy Versus Nicotine Reduction.


Sponsor

University of Auckland, New Zealand

Enrollment

774 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Inclusion Criteria8

  • 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 Criteria8

  • 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.

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Interventions

COMBINATION_PRODUCTNicotine patches plus nicotine mouth spray

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

OTHERNicotine 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.


Locations(1)

School of Population Health, Faculty of Medical and Health Sciences, University of Auckland

Auckland, New Zealand

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NCT06832098


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