Toxins and Delivery in e-Cigarette Users (TADEUS)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users|
- Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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.
- Change in nicotine levels after 4 weeks use of electronic cigarettes (EC) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only).
- Electronic cigarette acceptability [ Time Frame: 6 months ] [ Designated as safety issue: No ]Participants' views on electronic cigarettes
- Use of electronic cigarettes [ Time Frame: 6 months ] [ Designated as safety issue: No ]Participants' use of electronic cigarettes
Biospecimen Retention: Samples Without DNA
Urine is collected for analysis of a metabolite of acrolein (3-HPMA_.
Blood is collected for analysis of nicotine.
|Study Start Date:||February 2013|
|Study Completion Date:||January 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Smokers attempting to quit with behavioural support and e-Cigarettes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714778
|Queen Mary University of London|
|London, United Kingdom, E12JH|