Toxins and Delivery in e-Cigarette Users

Smoking Cessation Clinical Trial

— TADEUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714778
• Other study ID #: QMUL201208a
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: March 12, 2014
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• e-Cigarette

Locations

Country	Name	City	State
United Kingdom	Queen Mary University of London	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.	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.	4 weeks	Yes
Secondary	Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)	Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only).	4 weeks	No
Secondary	Electronic cigarette acceptability	Participants' views on electronic cigarettes	6 months	No
Secondary	Use of electronic cigarettes	Participants' use of electronic cigarettes	6 months	No