Adding an electronic-cigarette to standard behavioural treatment for low-socioeconomic status smokers: A randomised trial

image - E Cig
Date Commenced:
2017
Expected Date of Completion:
12/2020
Project Supporters:

NHMRC Project Grant (APP1127390)

Drug Type:
Project Members: 
image - Richard Mattick
Honorary Visiting Professor
Ph 02 9385 0333
image - Ryan Courtney
Senior Lecturer
Ph 02 8936 1004
image - Michael Farrell 0
Director
Ph EA Tori Barnes: 02 9385 0292 / t.barnes@unsw.edu.au
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Senior Research Officer
Ph 1800 319 250
image - VB NDARC 2016 Photo 1
Postdoctoral Fellow
Ph 02 9385 0333
Project Main Description: 

Smoking is a leading cause of preventable disease and death. Limited progress has occurred in reducing smoking rates over the past decade for the most disadvantaged Australians (2001 = 24%, 2013 = 21%) despite a two-fold reduction in smoking prevalence among the most advantaged Australians (2001 = 14%, 2013 = 7%). Facilitating smoking cessation in low-socioeconomic status (low-SES) smokers is a national health priority, yet there are scant evidence-based interventions.

One novel approach may be offered by vaporised nicotine products (nicotine vaporisers or electronic cigarettes containing nicotine) as a method to cease tobacco smoking, but the evidence for their value is missing. This lack of evidence has left the public health community understandably divided on the value and risks of nicotine vaporisers, with strong proponents for and against their use. Yet, both sides agree policy and regulatory decisions must be informed by evidence (which is currently lacking worldwide and urgently needed, given the apparent uptake of these devices).

Our aim is to test the efficacy, cost-effectiveness, and safety of nicotine vaporisers at increasing smoking cessation compared to standard treatment in low-SES smokers over a one-year period. We will conduct a rigorous, single-blinded, two-group randomised controlled trial (RCT) that compares smoking cessation rates between, two groups of 434 low-SES smokers (N = 868), randomly allocated to either: (1) a current Standard Treatment (ST) - oral form of Nicotine Replacement Therapy (gum/ lozenge); or (2) an Experimental Treatment (ET) e-cigarette. This work is of significance nationally and internationally.

We can provide high-quality evidence on the efficacy, cost-effectiveness, and safety of nicotine vaporisers as a smoking cessation aid.

Project Collaborators: External: 

Prof Ron Borland (Cancer Council Victoria)

Dr Coral Gartner (University of Queensland)

Prof Hayden McRobbie (Queen Mary University London)

A/Prof Dennis Petrie (Monash University)

Prof Mohammad Siahpush (University of Nebraska Medical Center)

Prof Robyn Richmond (UNSW)

Prof Christopher Doran (Central Queensland University)

Prof Colin Mendelsohn (UNSW)

Prof Nicholas Zwar (University of Wollongong)

Prof Wayne Hall (University of Queensland)

Rationale: 

Behavioural and pharmacological approaches to smoking cessation are effective at helping people to quit but long-term quit rates remain low, especially among low-SES Australians. Nicotine vaporiser may complement current treatment approaches. We will conduct a large-scale trial to determine if nicotine vaporisers can improve on the efficacy of existing treatments. The findings would have immediate practical implications that could reduce the preventable deaths of many tobacco smokers.

Aims: 

To test in a rigorous, single-blinded, two-group RCT whether a nicotine vaporiser significantly increases continuous smoking abstinence rates in Australian low-SES smokers compared with traditional oral nicotine products.

We will compare 6-month-continuous-abstinence rates at 7-month follow-up between two groups of 434 low-SES smokers (N = 868), randomly allocated to either:

(1) Standard treatment (ST): oral NRT (gum/lozenge); or

(2) Experimental treatment (ET): nicotine vaporiser and liquid nicotine.

Design and Method: 

Design. A two-group RCT (See Table 1) comparing smoking abstinence rates between:

(i) a standard treatment (ST) involving oral NRT (gum or lozenge); and

(ii) an experimental treatment (ET) involving a nicotine vaporiser (using 18mg/ml nicotine solution).

Recruitment. Low-SES smokers will be recruited through (1) Newspaper ads in community newspapers will target low-SES smokers. (2) Paid social media advertising will target specific regions. (3) Posters and flyers. Study posters will be posted on community noticeboards in medical practices and Centrelink offices and letter box flyers will be targeted to areas and suburbs with high smoking rates. Progress/Update 

Funding commenced in 2018

Recruitment to commence mid 2019.

Progress/Update: 

Funding to commence in 2017

Benefits: 

We will provide a world-first adequately-powered study of vaporised nicotine products compared to an existing standard treatment, focusing on the potential of nicotine vaporisers to provide a unique appeal to low-SES smokers.

We will produce the following outputs:

(i) the value of nicotine vaporisers  as a cessation aid;

(ii) the cost-effectiveness of this new experimental approach to smoking cessation;

(iii) any potential dangers of nicotine vaporisers in a large cohort to TGA standards over 7 months;

(iv) the potential that smokers will continue to rely on nicotine vaporisers and maintain nicotine dependence even if they cease smoking, and the relative potential for harm-reduction.

Significance. Vaporised nicotine products have sparked worldwide interest. Despite the rapid uptake of nicotine vaporisers, there is little high quality evidence on their value to reduce smoking rates. Increasing smoking cessation is imperative to reduce the adverse health consequences that are especially concentrated among low-SES smokers where health inequalities persist. Nicotine vaporisers may have an important role, but the magnitude of that role is undetermined.

The findings of this research will assist Australian and international decision-makers to make evidence-informed decisions.

Drug Type: 
Project Status: 
Current