Toxins and Delivery in e-Cigarette Users (TADEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01714778
First received: October 23, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: February 2013
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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

Locations
United Kingdom
Queen Mary University of London
London, United Kingdom, E12JH
Sponsors and Collaborators
Queen Mary University of London
  More Information

No publications provided

Responsible Party: 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: March 12, 2014
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on October 19, 2014