Toxins and Delivery in e-Cigarette Users (TADEUS)
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|ClinicalTrials.gov Identifier: NCT01714778|
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : March 13, 2014
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.
|Condition or disease||Intervention/treatment|
|Smoking Cessation||Other: e-Cigarette|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||January 2014|
Smokers attempting to quit with behavioural support and e-Cigarettes.
- Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes. [ Time Frame: 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.
- Change in nicotine levels after 4 weeks use of electronic cigarettes (EC) [ Time Frame: 4 weeks ]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 ]Participants' views on electronic cigarettes
- Use of electronic cigarettes [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714778
|Queen Mary University of London|
|London, United Kingdom, E12JH|