UK-Czech E-cigarette Study ((SUKCES))

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Standard care plus electronic cigarettes; Behavioral: Standard care

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2JH
    • Tobacco Dependence Research Unit, Queen Mary University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care plus electronic cigarettes; Standard care for smoking cessation plus electronic cigarettes	Other: Standard care plus electronic cigarettes
Other: Standard care; Standard care for smoking cessation	Other: Standard care plus electronic cigarettes; Behavioral: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD	Four weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Principal Investigator: Peter Hajek, PhD, Queen Mary University of London

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: QMUL201208b