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Completed

NCT Number: NCT01842828

UK-Czech E-cigarette 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tobacco Dependence Research Unit, Queen Mary University of London

London, E1 2JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care plus electronic cigarettes

Other

Standard Care

Behavioral

Primary outcomes

  1. Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD

    Time frame: Four weeks

Secondary outcomes

  1. Carbon monoxide (CO)-validated abstinence rates at 24 weeks post-TQD

    Time frame: Four weeks

  2. Ratings of cigarette withdrawal at 1 and 4 weeks post-TQD

    Time frame: Four weeks

  3. Electronic cigarette use

    Time frame: 24 weeks

  4. Electronic cigarette taste and satisfaction in comparison to conventional cigarettes

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: (SUKCES)

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2013
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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