Smoking Cessation Clinical Trial
Official title:
E-Cigarettes as an Addition to Multi-component Treatment for Tobacco Dependence: A Pilot Study
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.
The investigators plan to conduct a study 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 200 smokers would be recruited at smoking cessation clinics in London and Prague.
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.
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