UK-Czech E-cigarette Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Standard care plus electronic cigarettes
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokers who want help with quitting Aged 18 or over Exclusion Criteria: Pregnancy, breastfeeding, planning to conceive in the next 6 months Enrolled in other research Currently using electronic cigarettes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care plus electronic cigarettes<br>Standard care for smoking cessation plus electronic cigarettes | Other: Standard care plus electronic cigarettes<br> <br> |
| Other: Standard care<br>Standard care for smoking cessation | Other: Standard care plus electronic cigarettes<br> <br> Behavioral: Standard care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide (CO)-validated abstinence rates at 24 weeks post-TQD |  | Four weeks | 
| Ratings of cigarette withdrawal at 1 and 4 weeks post-TQD |  | Four weeks | 
| Electronic cigarette use |  | 24 weeks | 
| Electronic cigarette taste and satisfaction in comparison to conventional cigarettes |  | 24 weeks |