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 - 1333427146 Ryan Wurtrey 280
Research Fellow
Ph 02 8936 1004
image - Michael Farrell  Square
Director
Ph EA Jemma Sale: 02 9385 0292 / j.sale@unsw.edu.au
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 electronic cigarettes (e-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 e-cigarettes, 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 e-cigarettes 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) - Quitline support + oral form of Nicotine Replacement Therapy (gum/ lozenge); or (2) an Experimental Treatment (ET) - Quitline support + e-cigarette. This work is of significance nationally and internationally.

We can provide high-quality evidence on the efficacy, cost-effectiveness, and safety of e-cigarettes 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. The electronic cigarette may complement current treatment approaches. We will conduct a large-scale trial to determine if “e-cigarettes” 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 adding an electronic cigarette (e-cigarette) to Quitline support 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 12 month follow-up between two groups of 434 low-SES smokers (N = 868), randomly allocated to either:

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

(2) Experimental treatment (ET): Quitline support + e-cigarette containing 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) plus Quitline support; and

(ii) an experimental treatment (ET) involving an e-cigarette (using 18mg/ml nicotine solution) plus Quitline support.

 

Recruitment. Low-SES smokers will be recruited through (1) DHS Centrelink Customer Service Centres; (2) all state and territory Quitlines services and (3) local community newspaper advertisements.

Progress/Update: 

Funding to commence in 2017

Benefits: 

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

We will produce the following outputs:

(i) the value of e-cigarettes as a cessation aid;

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

(iii) any potential dangers of e-cigarettes in a large cohort to TGA standards over 12 months;

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

 

Significance. E-cigarettes have sparked worldwide interest. Despite the rapid uptake of e-cigarettes, 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. E-cigarettes 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