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Completed

NCT Number: NCT01714778

Toxins and Delivery in e-Cigarette 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary University of London

London, E12JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Cigarette

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Electronic cigarette acceptability

    Time frame: 6 months

    Participants' views on electronic cigarettes

  3. Use of electronic cigarettes

    Time frame: 6 months

    Participants' use of electronic cigarettes

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: TADEUS

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 26, 2012
Registry last updated
Mar 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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