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Trial record 1 of 1 for:    NCT01842828
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UK-Czech E-cigarette Study ((SUKCES))

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ClinicalTrials.gov Identifier: NCT01842828
Recruitment Status : Completed
First Posted : April 30, 2013
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Standard care plus electronic cigarettes Behavioral: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E-Cigarettes as an Addition to Multi-component Treatment for Tobacco Dependence: A Pilot Study
Study Start Date : December 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard care plus electronic cigarettes
Standard care for smoking cessation plus electronic cigarettes
Other: Standard care plus electronic cigarettes
Standard care
Standard care for smoking cessation
Other: Standard care plus electronic cigarettes
Behavioral: Standard care



Primary Outcome Measures :
  1. Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842828


Locations
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United Kingdom
Tobacco Dependence Research Unit, Queen Mary University of London
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Peter Hajek, PhD Queen Mary University of London
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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01842828    
Other Study ID Numbers: QMUL201208b
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: February 2016