Evidence map›Paper›PMID 36104702›Full record

ArticleTrials2022

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 and 9 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Trial
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 3 countries.

Bridget C HowardNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia. bridget.howard@unsw.edu.au.ORCID http://orcid.org/0000-0003-0080-4853
Hayden McRobbieNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Dennis PetrieCentre for Health Economics, Monash Business School, Monash University, Caufield, Australia.
Daniel BarkerHunter Medical Research Institute, New Lambton Heights, Australia.
Colin Mendelsohn, Sydney, Australia.
Jack AndersonNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Ron BorlandSchool of Psychological Sciences, University of Melbourne, Melbourne, Australia.
Felix NaughtonBehavioural and Implementation Science Group, School of Health Sciences, University of East Anglia, Norwich, UK.
Piotr TutkaDepartment of Experimental and Clinical Pharmacology, University of Rzeszow, Rzeszow, Poland.
Nick ZwarFaculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.
Veronica C BolandNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Alexandra AikenNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Anthony ShakeshaftNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Coral GartnerSchool of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, Australia.
Robyn L RichmondSchool of Population Health, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.
Wayne HallThe National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, Australia.
Richard P MattickNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Michael FarrellNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Ryan J CourtneyNational Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
UNSW Sydney · AUThe University of Queensland · AUBond University · AUHunter Medical Research Institute · AUMonash University · AUThe University of Melbourne · AUUniversity of East Anglia · GBUniversity of Rzeszów · PL

Funding

National Health and Medical Research Council APP1127390
6 · The paper itself

Abstract

backgroundIn 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.

methodsThis 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021.  https://www.anzctr.org.au.

Indexed as

AlcoholismSmoking CessationAustraliaCost-Benefit AnalysisEquivalence Trials as TopicHumansNicotianaNicotineRandomized Controlled Trials as TopicSocial ClassTobacco Use Cessation DevicesTreatment OutcomeNicotineCost-effectivenessElectronic cigarettesRandomized controlled trialSmoking cessationSocial disadvantageTobacco

Identifiers

PMID36104702
PMCPMC9473457
OpenAlexW4295700783

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.