Toxins and Delivery in e-Cigarette Users (TADEUS)

Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: e-Cigarette

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E12JH
    • 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

• Sampling Method: Non-Probability Sample

Study Population

Smokers from the community who wish to stop smoking.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
e-Cigarette; Smokers attempting to quit with behavioural support and e-Cigarettes.	Other: e-Cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.	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.	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (ESTIMATE): October 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: QMUL201208a