Toxins and Delivery in e-Cigarette Users

Completed

• Conditions: Smoking Cessation
• Interventions: Other: e-Cigarette

• Registration Number: NCT01714778
• Lead Sponsor: Queen Mary University of London

Brief Summary

Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects.

To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time.

To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting.

This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-26
• Study Start: 2013-02
• Primary Completion: 2013-09
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Women who are pregnant or breastfeeding
• People with any current serious illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
e-Cigarette	e-Cigarette	Smokers attempting to quit with behavioural support and e-Cigarettes.

Primary Outcome Measures

Name	Time	Method
Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.	4 weeks	Change in urinary 3HPMA levels (a metabolite of acrolein) after 4 weeks use of electronic cigarettes, in both individuals who have stopped smoking conventional cigarettes and those who are still using them.

Secondary Outcome Measures

Name	Time	Method
Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)	4 weeks	Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only).
Use of electronic cigarettes	6 months	Participants' use of electronic cigarettes
Electronic cigarette acceptability	6 months	Participants' views on electronic cigarettes

Trial Locations

Locations (1)

Queen Mary University of London; 🇬🇧 London, United Kingdom