Smoking CessationTADEUSNCT01714778
Toxins and Delivery in e-Cigarette Users
An observational study of Smoking Cessation, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- e-Cigarette
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Smokers from the community who wish to stop smoking.
Who may be able to join
- Smokers who want help in quitting
- Aged 18 or over
Who cannot join
- Women who are pregnant or breastfeeding
- People with any current serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in 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.
Read more
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
- Being tested
- e-Cigarette
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-CigaretteOther
| Study group | Role | What they receive |
|---|---|---|
| e-Cigarette | Smokers attempting to quit with behavioural support and e-Cigarettes. Receives: Other: e-Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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).
Measured: 4 weeks
Electronic cigarette acceptability
Participants' views on electronic cigarettes
Measured: 6 months
Use of electronic cigarettes
Participants' use of electronic cigarettes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714778
- Sponsor's protocol ID
- QMUL201208a
- Acronym
- TADEUS
- Status last verified
- Mar 2014
- First submitted
- 23 Oct 2012
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users
- ClinicalTrials.gov ID
- NCT01714778
- Acronym / sponsor ID
- TADEUS / QMUL201208a
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e-Cigarette | – | Other: e-CigaretteSmokers attempting to quit with behavioural support and e-Cigarettes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Smokers from the community who wish to stop smoking.
Key inclusion criteria (2 listed)
- Smokers who want help in quitting
- Aged 18 or over
Key exclusion criteria (2 listed)
- Women who are pregnant or breastfeeding
- People with any current serious illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-Cigarette | Other | e-Cigarette |
Primary outcome
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.
3 secondary outcomes
Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)
Time frame: 4 weeks
Electronic cigarette acceptability
Time frame: 6 months
Use of electronic cigarettes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.