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UK-Czech E-cigarette Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01842828
Acronym
(SUKCES)
Enrollment
199
Registered
2013-04-30
Start date
2013-12-31
Completion date
2017-01-31
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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.

Interventions

OTHERStandard care plus electronic cigarettes
BEHAVIORALStandard care

Sponsors

Queen Mary University of London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQDFour weeks

Secondary

MeasureTime frame
Carbon monoxide (CO)-validated abstinence rates at 24 weeks post-TQDFour weeks
Ratings of cigarette withdrawal at 1 and 4 weeks post-TQDFour weeks
Electronic cigarette use24 weeks
Electronic cigarette taste and satisfaction in comparison to conventional cigarettes24 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026