Clinical trial NCT01842828: UK-Czech E-cigarette Study
Official title: E-Cigarettes as an Addition to Multi-component Treatment for Tobacco Dependence: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD
timeFrame: Four weeks
Secondary outcomes:
measure: Carbon monoxide (CO)-validated abstinence rates at 24 weeks post-TQD
timeFrame: Four weeks
measure: Ratings of cigarette withdrawal at 1 and 4 weeks post-TQD
timeFrame: Four weeks
measure: Electronic cigarette use
timeFrame: 24 weeks
measure: Electronic cigarette taste and satisfaction in comparison to conventional cigarettes
timeFrame: 24 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research Unit, Queen Mary University of London
Study officials:
affiliation: Queen Mary University of London
name: Peter Hajek, PhD
role: PRINCIPAL_INVESTIGATOR
References: