NCT01842828

UK-Czech E-cigarette Study

E-Cigarettes as an Addition to Multi-component Treatment for Tobacco Dependence: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
OTHER	Standard care plus electronic cigarettes
BEHAVIORAL	Standard care

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-04-30
• Last updated: 2019-09-04

Locations

1 site across 1 country: United Kingdom