UK-Czech Republic E-cigarette Study
Research type
Research Study
Full title
E-cigarettes as an addition to multi-component treatment for tobacco dependence: A pilot study
IRAS ID
122612
Contact name
Peter Hajek
Contact email
Sponsor organisation
Queen Mary, University of London
Clinicaltrials.gov Identifier
Research summary
Currently available smoking cessation treatments help only about 15% of smokers to quit long-term. These treatments do not typically address the behaviours and sensations associated with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of smoke on the throat). There is evidence that these elements influence smoking behaviour and cessation. Electronic cigarettes (EC) are a new product with a strong potential to be a realistic behavioural replacement for smoking.
Whilst EC deliver nicotine, their use does not involve tobacco combustion, which is the primary source of the many thousands of dangerous chemicals to which smokers of conventional cigarettes are exposed. Studies on EC products and users indicate there is little doubt that they are substantially safer than conventional cigarettes.
We plan to conduct one of the very first studies to test the effects of adding EC to standard care on long-term validated outcomes. Before launching such a large and demanding trial however, data are needed on what proportion of smokers would be interested in using EC and what compliance with EC use can be expected, and no data exist to inform how large a sample is needed. This pilot study would provide such data.
A total of 350 smokers would be randomised at smoking cessation clinics in London, Madrid, and Prague. Within each site, half the smokers would be randomised to receive standard smoking cessation behavioural support and medication (standard care; SC), and half to receive SC plus EC. The EC group would receive a four week supply of EC. The outcome measures for the study would be smoking status at 4 and 24 weeks after the target quit date, EC use, acceptability, and adverse events.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/0936
Date of REC Opinion
24 Jul 2013
REC opinion
Favourable Opinion