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
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
Treatments tested in this trial
- Nicotine patches plus nicotine mouth spray
- Nicotine Tapering Plan
Treatment groups
774 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Auckland, New Zealand
Lead sponsor
University College, London
Collaborator
Medical University of South Carolina
Collaborator
Flinders University
Collaborator
Source ClinicalTrials.gov