Toxins and Delivery in e-Cigarette Users

NCT01714778 | Completed

• 1 other identifier: QMUL201208a
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)

  4 weeks

• Electronic cigarette acceptability

  6 months

• Use of electronic cigarettes

  6 months

Study Arms (1)

e-Cigarette

Smokers attempting to quit with behavioural support and e-Cigarettes.

Other: e-Cigarette

Interventions

e-Cigarette OTHER

e-Cigarette

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Smokers from the community who wish to stop smoking.

You may qualify if:

• Smokers who want help in quitting
• Aged 18 or over

You may not qualify if:

• Women who are pregnant or breastfeeding
• People with any current serious illness

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, E12JH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine is collected for analysis of a metabolite of acrolein (3-HPMA\_. Blood is collected for analysis of nicotine.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 26, 2012
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

GB (1)