UK-Czech E-cigarette Study

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Other: Standard care plus electronic cigarettes; Behavioral: Standard care

• Registration Number: NCT01842828
• Lead Sponsor: Queen Mary University of London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-30
• Study Start: 2013-12
• Status Verified: 2016-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care plus electronic cigarettes	Standard care for smoking cessation
Standard care	Standard care	Standard care for smoking cessation
Standard care plus electronic cigarettes	Standard care plus electronic cigarettes	Standard care for smoking cessation plus electronic cigarettes

Primary Outcome Measures

Name	Time	Method
Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD	Four weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tobacco Dependence Research Unit, Queen Mary University of London; 🇬🇧 London, United Kingdom