Toxins and Delivery in e-Cigarette Users (TADEUS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01714778 |
Recruitment Status :
Completed
First Posted : October 26, 2012
Last Update Posted : March 13, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

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
United Kingdom | |
Queen Mary University of London | |
London, United Kingdom, E12JH |
Responsible Party: | Queen Mary University of London |
ClinicalTrials.gov Identifier: | NCT01714778 History of Changes |
Other Study ID Numbers: |
QMUL201208a |
First Posted: | October 26, 2012 Key Record Dates |
Last Update Posted: | March 13, 2014 |
Last Verified: | March 2014 |