Toxins and Delivery in e-Cigarette Users (TADEUS)

This study is not yet open for participant recruitment.
Verified October 2012 by Queen Mary University of London
Sponsor:
Information provided by (Responsible Party):
Oliver West, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01714778
First received: October 23, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention
Smoking Cessation
Other: e-Cigarette

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Groups/Cohorts Assigned Interventions
e-Cigarette
Smokers attempting to quit with behavioural support and e-Cigarettes.
Other: e-Cigarette

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Smokers from the community who wish to stop smoking.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714778

Contacts
Contact: Oliver West, MSc o.west@qmul.ac.uk

Locations
United Kingdom
Queen Mary University of London Not yet recruiting
London, United Kingdom, E12JH
Sponsors and Collaborators
Oliver West
  More Information

No publications provided

Responsible Party: Oliver West, Research Fellow, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01714778     History of Changes
Other Study ID Numbers: QMUL201208a
Study First Received: October 23, 2012
Last Updated: October 23, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013