Trial of Electronic Cigarettes (TEC)
Research type
Research Study
Full title
A randomised controlled trial to examine the efficacy of e-cigarettes compared with nicotine replacement therapy, when used within the UK stop smoking service
IRAS ID
159589
Contact name
Hayden McRobbie
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Electronic cigarettes (EC) are increasingly popular as a means of reducing/stopping smoking. They mimic the sensations of smoking while delivering, in a mist, nicotine levels similar to nicotine replacement treatment (NRT). Nicotine itself is relatively harmless and no clinically significant levels of harmful chemicals have been detected in EC vapour. Because EC are popular and inexpensive compared with NRT, it is important to find out if they match in efficacy.
This study will compare the efficacy of EC with NRT; 886 smokers wanting help to quit will be randomly assigned to receive standard NRT of their choice, or an EC, and both groups will receive usual care behavioural support provided by a stop smoking service (SSS). We will use a second generation EC (these do not look like cigarettes and give more reliable nicotine delivery). We will provide participants with an EC starter pack but they will then be encouraged to buy their own e-liquid. The NRT group will access NRT as per the SSS' standard practice (e.g. Tower Hamlets SSS supply NRT on a letter of recommendation (a local scheme for supplying NRT) weekly for the first 4 weeks and pay prescription charges if applicable. All participants will be followed up at 6 and 12 months, and those abstinent at 12 months or who have reduced their cigarette consumption by at least half will have a carbon-monoxide (CO) breath test to confirm this.
The main outcome is sustained, CO validated abstinence from smoking at a year. We will also collect information on NRT/EC use, side effects, and reduction in cigarette consumption. Finally the cost of interventions will be compared.
If EC were found to be as effective as NRT, this could improve the reach and reduce the cost of stop smoking treatments, potentially saving the lives of many smokers.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
14/LO/2235
Date of REC Opinion
18 Dec 2014
REC opinion
Favourable Opinion