Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial

Bridget C Howard; Hayden McRobbie; Dennis Petrie; Daniel Barker; Colin Mendelsohn; Jack Anderson; Ron Borland; Felix Naughton; Piotr Tutka; Nick Zwar; Veronica C Boland; Alexandra Aiken; Anthony Shakeshaft; Coral Gartner; Robyn L Richmond; Wayne Hall; Richard P Mattick; Michael Farrell; Ryan J Courtney

doi:10.1186/s13063-022-06644-8

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Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial

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Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial

Bridget C Howard, Hayden McRobbie, Dennis Petrie, Daniel Barker, Colin Mendelsohn, Jack Anderson, Ron Borland, Felix Naughton, Piotr Tutka, Nick Zwar, …

Trials, Vol.23, pp.1-12

2022

DOI: https://doi.org/10.1186/s13063-022-06644-8

PMID: 36104702

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Abstract

cost-effectiveness

electronic cigarettes

randomized controlled trial

smoking cessation

social disadvantage

Tobacco

Background In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]—gum or lozenge) for smoking cessation. Methods This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. Discussion Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021. https://www.anzctr.org.au

Details

Title: Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial
Authors: Bridget C Howard (Corresponding Author) - UNSW Sydney
Hayden McRobbie - UNSW Sydney
Dennis Petrie - Monash University
Daniel Barker - Hunter Medical Research Institute
Colin Mendelsohn
Jack Anderson - UNSW Sydney
Ron Borland - The University of Melbourne
Felix Naughton - University of East Anglia
Piotr Tutka - University of Rzeszów
Nick Zwar - Bond University
Veronica C Boland - UNSW Sydney
Alexandra Aiken - UNSW Sydney
Anthony Shakeshaft - UNSW Sydney
Coral Gartner - The University of Queensland
Robyn L Richmond - UNSW Sydney
Wayne Hall - The University of Queensland
Richard P Mattick - UNSW Sydney
Michael Farrell - UNSW Sydney
Ryan J Courtney - UNSW Sydney
Publication details: Trials, Vol.23, pp.1-12
Publisher: BioMed Central Ltd.
Date published: 2022
DOI: 10.1186/s13063-022-06644-8
ISSN: 1745-6215
PMID: 36104702
Copyright note: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Data Availability: Trial data are available on request to the Principal Investigator of the study.
Grants: Reducing the social gradient in tobacco smoking rates: The road less travelled; Novel and innovative paths for improved cessation rates and outcomes, 1148497, National Health and Medical Research Council (Australia, Canberra) - NHMRC
Adding an electronic-cigarette to standard behavioural treatment for low-socioeconomic status smokers: A randomised trial., 1127390, National Health and Medical Research Council (Australia, Canberra) - NHMRC
Organisation Unit: School of Health - Psychology
Language: English
Record Identifier: 991241460902621
Output Type: Journal article

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