UK-Czech E-cigarette Study

Smoking Cessation Clinical Trial

— (SUKCES)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842828
• Other study ID #: QMUL201208b
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Standard care plus electronic cigarettes

Behavioral:
• Standard care

Locations

Country	Name	City	State
United Kingdom	Tobacco Dependence Research Unit, Queen Mary University of London	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD		Four weeks
Secondary	Carbon monoxide (CO)-validated abstinence rates at 24 weeks post-TQD		Four weeks
Secondary	Ratings of cigarette withdrawal at 1 and 4 weeks post-TQD		Four weeks
Secondary	Electronic cigarette use		24 weeks
Secondary	Electronic cigarette taste and satisfaction in comparison to conventional cigarettes		24 weeks