A trial of the effectiveness of e-cigarettes as an aid to smoking cessation.

Rationale

Most people find it difficult to succeed in quit attempts largely because of dependence on nicotine but also to non-nicotine sensory cues. Nicotine replacement therapy (NRT) doubles quit rates by making the transition to non-smoker less traumatic. Nevertheless, absolute long-term quit rates are low. A product that has potential as a cessation aid and with wider appeal than NRTs is the electronic cigarette. People buy them to help quit smoking, reduce cigarette consumption and costs, to relieve tobacco withdrawal symptoms or as a replacement for smoking. However, despite the claims of efficacy and popularity there is no evidence from trials of their efficacy on quitting and safety.

Aims

To evaluate the quitting efficacy, acceptability, and adverse effects of an e-cigarette, comparing active (16mg nicotine) with nicotine patch and placebo (0mg nicotine) e-cigarettes.

Design

A three arm parallel group randomised controlled trial.  Participants will be randomised into either a group who will use active e-cigarette for 12 weeks after quitting, nicotine patches for 12 weeks or placebo e-cigarettes for 12 weeks. Quit rates will be assessed at 3 and 6 months after the quit date.

Study Status

This study is ongoing and open to recruitment.

Funding

This study is funded by the Health Research Council of New Zealand.

CTRU Contact

Chris Bullen, Principal Investigator

CTRU’s Role

The CTRU was involved in all aspects of study development, design and securing funding for this trial.  In addition the CTRU is responsible for trial co-ordination, data management, data analysis and reporting.

Collaborators

This study is being conducted in collaboration with:
Health New Zealand, Christchurch, New Zealand
Inspiring Ltd, Auckland New Zealand

Publications

• Etter, J., & BULLEN, C. Electronic cigarette: Users profile, utilization, satisfaction and perceived efficacy. Addiction 2011;106 (11):2017-2028.
• Etter J-F, BULLEN C, Flouris A, Laugesen M, Eissenberg T. Electronic nicotine delivery systems: A research agenda. Tobacco Control 2011;20:243-248 doi:10.1136/tc.2010.042168.
• Etter J-F, BULLEN C. Saliva cotinine levels in users of electronic nicotine delivery systems. Eur Resp J 2011 May (Letter).
• Etter J-F, BULLEN C, Flouris A, Laugesen M, Eissenberg T. Electronic nicotine delivery systems: A research agenda. Tobacco Control 2011 Mar 17. [Epub ahead of print]
• BULLEN C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tobacco Control 2010;19(2):98-103.