SmokingNCT02752022
Monitoring the Transition From Smoking to E-cigarettes
An observational study of Smoking, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their usage is currently under way. People purchase them as an aid to giving up smoking, to reduce cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban smoking, and in order to continue smoking… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to 1 Apr 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Heavy smokers (continuous smoking of >10 cigarettes per day) for at least 6 months who are willing to give up smoking and switch to nicotine containing e-cigarettes to help them quit smoking
Who may be able to join
- Heavy smokers (continuous smoking of >10 cigarettes per day) for at least 6 months who are willing to give up smoking and switch to nicotine containing e-cigarettes to help them quit smoking.
- Males and females aged 18-65 years
- Subjects must be willing and able to give informed consent
- Subjects must have understanding of English sufficient that they are able to read and understand the participant information sheet and the informed consent form
- Subjects in the opinion of the Investigator are healthy on the basis of medical history questionnaire and vital signs
- Subjects who will purchase their e-cigarettes kits, e-liquid and/or cartridges from a pharmacy, leading super market, established newsagent chain)
Who cannot join
- Severe psychosis, Bipolar Affective Disorder I, prostate cancer, Cushing's syndrome, severe depression with suicidal ideation and intention, brain trauma or other severe neurological disorders (e.g. pan-hypopituitarism) or taking antidepressants, anxiolytics antipsychotics
- Pregnant females and lactating mothers
- History of substance abuse and alcoholism
- History of cardiovascular disease (heart disease, angina, heart attacks, high blood pressure, heart surgery) in the last 6 months.
- Self-declared smokers with low or non-detectable CO readings in their breath when tested with the oxymeter will be excluded from further being studied
- Smokers who are undergoing alternative Nicotine Replacement Therapy (NRT)/pharmacological treatment for smoking cessation (i.e. nicotine patches, nicotine gum, Champix, bupropion)
- Any other condition that in the judgement of the investigator would preclude participation
- Smokers who are unwilling to refrain from smoking for 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Levels of Tobacco-specific Nitrosamines, DNA Adducts, Stress Hormones and DNA Methylation During the Transition From Cigarette Smoking to Electronic Cigarette Use: a Prospective Observational Study
Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their usage is currently under way. People purchase them as an aid to giving up smoking, to reduce cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban smoking, and in order to continue smoking with decreased health risks. Although the safety and impact on health of electronic cigarettes, especially after long-term use, has not been evaluated, they are generally considered to be far safer alternatives to cigarette smoke. Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of carcinogenic chemicals generated during the combustion of tobacco and making important contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific nitrosamines have been encountered in e-cigarettes being detected in some nicotine cartridges as contaminants, albeit at very low concentrations in comparison with tobacco smoke. Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming nicotine intake through electronic cigarettes. This European Commission funded study will monitor levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who give up smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels of other compounds which are known to be associated with smoking toxicity, such as DNA adducts and DNA methylation, will also be monitored in biological fluids of these subjects. Finally, cigarette craving, mood, anxiety, social anxiety, well-being status and stress hormones will be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the psychological effect of the transition. The results from the study will provide important information on the safety and effectiveness of e-cigarettes for smoking cessation which investigators anticipate to drive policy.
Read the detailed description
Established smokers will completely stop smoking for 4 weeks and instead transition to nicotine use through an electronic cigarette as required. They will be free to purchase the e-cigarette and e-liquid/cartridges of their own choice.
Eligible subjects will be asked to visit St George's Clinical Research Facility to provide the following samples. Blood, saliva and buccal cells to be collected on screening day. 24hr urine, blood, saliva and buccal cells will be collected at baseline and on days 3, 7, 21 and 28 after the first transition to e-cigarette use.
Moreover, subjects will be breathalysed with carbon monoxide (CO) oximeter and their urine analysed for anatabine to assess compliance to the study protocol (complete refrain of use of tobacco cigarettes for 4 weeks while they use e-cigarettes).
Subjects will be monitored for craving, mood, social anxiety, sleep profile and quality of life on every visit to St George's Clinical Research Facility (quality of life will be assessed only at baseline and day 28 of e-cigarette use). The subjects will be followed up with a telephone call 6 and 12 months after the end of the e-cigarette intervention to monitor their smoking/e-cigarette use behaviour and participants craving, mood, social anxiety, sleep profile and quality of life.
- Conditions
- Smoking
- Keywords
- e-cigarettes, nitrosamines, smoking cessation
- Medical subject headings
- Smoking, Vaping, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heavy smokers | Heavy smokers (continuous smoking of >10 cigarettes per day) for at least 6 months who will give up smoking and switch to nicotine containing e-cigarettes for 28 days to help them quit smoking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of levels of DNA adducts analysed by high resolution liquid chromatography
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of tobacco specific nitrosamines analysed by high resolution liquid chromatography
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of stress hormones analysed by ELISA
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of DNA methylation analysed by high pressure liquid chromatography-UV
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Secondary outcomes (9)
Change of measures of withdrawal symptoms severity measured by the Fagerstrom test
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of craving analysed by Minnesota Nicotine Withdrawal Scale
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of mood analysed by Mood and Physical Symptoms Scale (MPSS)
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of anxiety analysed by State-Trait Anxiety Inventory
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of social anxiety analysed by Liebovitz Social Anxiety Test
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measures of depression analysed by Beck Depression Inventory
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measures of sleep analysed by Pittsburg Sleep Index or Karolinska sleep questionaire
Measured: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measure of quality of life analysed by the European Quality of Life Questionnaire (EuroQL-5D)
Measured: baseline and 28 days following transition to e-cigarettes
Changes in brain electrical activity measured by EEG
Measured: baseline and 21 days following transition to e-cigarettes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startSep 2016
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Bailey, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752022
- Sponsor's protocol ID
- 16.0070
- Status last verified
- Jan 2019
- First submitted
- 13 Apr 2016
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Levels of Tobacco-specific Nitrosamines, DNA Adducts, Stress Hormones and DNA Methylation During the Transition From Cigarette Smoking to Electronic Cigarette Use: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02752022
- Acronym / sponsor ID
- 16.0070
- Conditions
- Smoking
- Keywords
- e-cigarettes, nitrosamines, smoking cessation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 26 Apr 2016 (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 (e-cigarettes) have proved very popular and a meteoric rise in their usage is currently under way. People purchase them as an aid to giving up smoking, to reduce cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban smoking, and in order to continue smoking with decreased health risks. Although the safety and impact on health of electronic cigarettes, especially after long-term use, has not been evaluated, they are generally considered to be far safer alternatives to cigarette smoke. Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of carcinogenic chemicals generated during the combustion of tobacco and making important contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific nitrosamines have been encountered in e-cigarettes being detected in some nicotine cartridges as contaminants, albeit at very low concentrations in comparison with tobacco smoke. Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming nicotine intake through electronic cigarettes. This European Commission funded study will monitor levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who give up smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels of other compounds which are known to be associated with smoking toxicity, such as DNA adducts and DNA methylation, will also be monitored in biological fluids of these subjects. Finally, cigarette craving, mood, anxiety, social anxiety, well-being status and stress hormones will be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the psychological effect of the transition. The results from the study will provide important information on the safety and effectiveness of e-cigarettes for smoking cessation which investigators anticipate to drive policy.
Detailed description
Established smokers will completely stop smoking for 4 weeks and instead transition to nicotine use through an electronic cigarette as required. They will be free to purchase the e-cigarette and e-liquid/cartridges of their own choice.
Eligible subjects will be asked to visit St George's Clinical Research Facility to provide the following samples. Blood, saliva and buccal cells to be collected on screening day. 24hr urine, blood, saliva and buccal cells will be collected at baseline and on days 3, 7, 21 and 28 after the first transition to e-cigarette use.
Moreover, subjects will be breathalysed with carbon monoxide (CO) oximeter and their urine analysed for anatabine to assess compliance to the study protocol (complete refrain of use of tobacco cigarettes for 4 weeks while they use e-cigarettes).
Subjects will be monitored for craving, mood, social anxiety, sleep profile and quality of life on every visit to St George's Clinical Research Facility (quality of life will be assessed only at baseline and day 28 of e-cigarette use). The subjects will be followed up with a telephone call 6 and 12 months after the end of the e-cigarette intervention to monitor their smoking/e-cigarette use behaviour and participants craving, mood, social anxiety, sleep profile and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heavy smokers | – | –Heavy smokers (continuous smoking of >10 cigarettes per day) for at least 6 months who will give up smoking and switch to nicotine containing e-cigarettes for 28 days to help them quit smoking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Heavy smokers (continuous smoking of >10 cigarettes per day) for at least 6 months who are willing to give up smoking and switch to nicotine containing e-cigarettes to help them quit smoking
Key inclusion criteria (6 listed)
- Heavy smokers (continuous smoking of >10 cigarettes per day) for at least 6 months who are willing to give up smoking and switch to nicotine containing e-cigarettes to help them quit smoking.
- Males and females aged 18-65 years
- Subjects must be willing and able to give informed consent
- Subjects must have understanding of English sufficient that they are able to read and understand the participant information sheet and the informed consent form
- Subjects in the opinion of the Investigator are healthy on the basis of medical history questionnaire and vital signs
Key exclusion criteria (8 listed)
- Severe psychosis, Bipolar Affective Disorder I, prostate cancer, Cushing's syndrome, severe depression with suicidal ideation and intention, brain trauma or other severe neurological disorders (e.g. pan-hypopituitarism) or taking antidepressants, anxiolytics antipsychotics
- Pregnant females and lactating mothers
- History of substance abuse and alcoholism
- History of cardiovascular disease (heart disease, angina, heart attacks, high blood pressure, heart surgery) in the last 6 months.
- Self-declared smokers with low or non-detectable CO readings in their breath when tested with the oxymeter will be excluded from further being studied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of levels of DNA adducts analysed by high resolution liquid chromatography
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of tobacco specific nitrosamines analysed by high resolution liquid chromatography
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of stress hormones analysed by ELISA
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of DNA methylation analysed by high pressure liquid chromatography-UV
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
9 secondary outcomes
Change of measures of withdrawal symptoms severity measured by the Fagerstrom test
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of craving analysed by Minnesota Nicotine Withdrawal Scale
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of mood analysed by Mood and Physical Symptoms Scale (MPSS)
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of anxiety analysed by State-Trait Anxiety Inventory
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of social anxiety analysed by Liebovitz Social Anxiety Test
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measures of depression analysed by Beck Depression Inventory
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measures of sleep analysed by Pittsburg Sleep Index or Karolinska sleep questionaire
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measure of quality of life analysed by the European Quality of Life Questionnaire (EuroQL-5D)
Time frame: baseline and 28 days following transition to e-cigarettes
Changes in brain electrical activity measured by EEG
Time frame: baseline and 21 days following transition to e-cigarettes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Alexis Bailey principal investigator
St George's, University of London
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, run by St George's, 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Jan 2019. 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?
Results are not available in the source record.
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 of levels of DNA adducts analysed by high resolution liquid chromatography (time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes). The study lists 4 primary outcomes in all. 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 17 Jan 2019.