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. 2022 Sep 14;23(1):777.
doi: 10.1186/s13063-022-06644-8.

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  1 , Hayden McRobbie  2 , Dennis Petrie  3 , Daniel Barker  4   5 , Colin Mendelsohn  6 , Jack Anderson  2 , Ron Borland  7 , Felix Naughton  8 , Piotr Tutka  9 , Nick Zwar  10   11 , Veronica C Boland  2 , Alexandra Aiken  2 , Anthony Shakeshaft  2 , Coral Gartner  12 , Robyn L Richmond  11 , Wayne Hall  13 , Richard P Mattick  2 , Michael Farrell  2 , Ryan J Courtney  2
Affiliations

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 et al. Trials. .

Abstract

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.

Keywords: Cost-effectiveness; Electronic cigarettes; Randomized controlled trial; Smoking cessation; Social disadvantage; Tobacco.

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Conflict of interest statement

No authors have received financial support from any companies for the submitted work. D.P. provides advice to the Australian Government Department of Health on funding decisions. C.M. was the founding chairman of the Australian Tobacco Harm Reduction Association a health promotion charity. He stepped down from the board in January 2021. Australian Tobacco Harm Reduction Association received funding from the vape industry to establish the charity. Funding was ceased in March 2019. He has not received any payments from electronic cigarette or tobacco companies. N. Z. is chair of an Expert Advisory Group for the Royal Australian College of General Practitioners smoking cessation guidelines. M.F. receives unrestricted research funding from Seqirus and Indivior.

Figures

Fig. 1
Fig. 1
Study flow diagram
See this image and copyright information in PMC

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