UK-Czech E-cigarette Study

NCT01842828 | Completed

• 1 other identifier: QMUL201208b
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

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

  Four weeks

Secondary Outcomes (4)

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

  Four weeks

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

  Four weeks

• Electronic cigarette use

  24 weeks

• Electronic cigarette taste and satisfaction in comparison to conventional cigarettes

  24 weeks

Study Arms (2)

Standard care plus electronic cigarettes

ACTIVE COMPARATOR

Standard care for smoking cessation plus electronic cigarettes

Other: Standard care plus electronic cigarettes

Standard care

OTHER

Standard care for smoking cessation

Other: Standard care plus electronic cigarettes; Behavioral: Standard care

Interventions

Standard care plus electronic cigarettes OTHER

Standard care; Standard care plus electronic cigarettes

Standard care BEHAVIORAL

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers who want help with quitting
• Aged 18 or over

You may not qualify if:

• Pregnancy, breastfeeding, planning to conceive in the next 6 months
• Enrolled in other research
• Currently using electronic cigarettes

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Tobacco Dependence Research Unit, Queen Mary University of London

London, E1 2JH, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Peter Hajek, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 30, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 4, 2019

Record last verified: 2016-02

Locations

GB (1)