Evidence map›Paper›PMID 23496861›Full record

Trial reportBMC public health2013

Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.

Chris Bullen, Jonathan Williman, Colin Howe, Murray Laugesen, Hayden McRobbie, Varsha Parag, Natalie Walker

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02422914 (Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program), which is not on this map. Cited by 32 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 13 pooled it
11.5field-weighted citation impact, top 1% 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.

NCT02422914 naunknown statusnot on this mapstarted 2014, after this paper: background citation

Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study

TypeinterventionalSponsorUniversity of MilanRan2014 to 2015Enrolled210ConditionsCigarette Smoking, Smoking CessationArmsSmoking cessation program TFC and activity tracker, Smoking cessation program TFC-free and activity tracker, Smoking cessation program and activity tracker
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 13 syntheses or guidelines pooled it, 110 citations in OpenAlex.

  1. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025
    Pooled it
  4. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2024
    Pooled it
  5. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2022
    Pooled it
  6. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  7. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  8. Pooled it
  9. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2020
    Pooled it
  10. Pooled it
  11. Is there a role for e-cigarettes in smoking cessation?Therapeutic advances in respiratory disease · 2016
    Pooled it
  12. Pooled it
  13. Pooled it
  14. A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2017
    Trial
  15. An Open Trial of Electronic Cigarettes for Smoking Cessation Among Methadone-Maintained Smokers.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Trial
  16. Trial
  17. Review
  18. Article
  19. Article
  20. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2016
    Review
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

7 authors at 5 institutions in 3 countries.

Chris BullenNational Institute for Health Innovation, School of Population Health, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand. c.bullen@nihi.auckland.ac.nz
Jonathan Williman
Colin Howe
Murray Laugesen
Hayden McRobbie
Varsha Parag
Natalie Walker
National Institutes of Health · USAuckland University of Technology · NZQueen Mary University of London · GBUniversity of Auckland · NZUniversity of Otago · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElectronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. METHODS/

design

designParallel group, 3-arm, randomised controlled trial.

participantsPeople aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking.

interventionStratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. PARTICIPANTS randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. PRIMARY OUTCOME: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. SAMPLE SIZE: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. DISCUSSION: This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an alternative smoking cessation aid to standard nicotine products.

trial registrationAustralian NZ Clinical Trials Registry (ACTRN12610000866000).

Indexed as

Electrical Equipment and SuppliesSmoking PreventionTobacco Use Cessation DevicesAdultFemaleFollow-Up StudiesHumansMaleNew ZealandOutcome Assessment, Health CareResearch DesignSmokingSmoking CessationTime Factors

Identifiers

PMID23496861
PMCPMC3602285
OpenAlexW2003522843

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.