Smoking, TobaccoNCT05953220
Investigating Exposure to Toxicants From Smoking and Vaping
An observational study of Smoking, Tobacco and Vaping, run by King's College London at 1 site in United Kingdom.
Trial summary
Background: Many people who smoke use vaping products to help them quit. Levels of toxicants in urine samples are substantially lower in those who exclusively vape compared to those who smoke, suggesting that vaping poses only a fraction of the harms as smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco, Vaping, Mental Health Disorder
- What is being tested?
- Exclusive tobacco smoking, Exclusive e-cigarette use and Dual use of e-cigarettes and tobacco smoking
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2023to Jan 2025
- 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: People from London who use community mental health services
Who may be able to join
- People aged 18 and over
- People who use community mental health services (including those who attend clozapine clinics)
- And one of the 4 categories:
- Exclusive smokers - people who smoke tobacco cigarettes at least daily and have not vaped an e-cigarette (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication or other tobacco products for the past 6 months.
- Exclusive vapers- people who vape e-cigarettes at least daily and have not smoked tobacco cigarettes (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication, or any other tobacco product for the past 6 months.
- Dual users- People who smoke tobacco cigarettes at least daily and also vape e-cigarettes at least once a week, and have not used NRT, smoking cessation medication, nor any other tobacco product for the past 6 months.
- People who vape e-cigarettes at least daily and also smoke cigarettes at least once a week, and have not used NRT, smoking cessation medication, nor any other tobacco product for the past 6 months.
- Non-users - people who have neither smoked, vaped used NRT, smoking cessation medication, nor any other tobacco product for the past 12 months.
Who cannot join
- Under the age of 18 years old.
- Unable to give informed consent.
- Unstable mental state defined as 1) severity of symptoms that render the patient unresponsive, unsociable, uncooperative, aggressive 2) memory impairment from head trauma or impaired ability to sustain concentration. To be assessed by clinical recruiting staff from medical records.
- Taking part in another study, experiment or clinical trial in which there is an intervention to alter their smoking/ vaping behaviour.
- Prescribed antibiotics in the past 14 days (recent infection will skew inflammation marker levels)
- Prescribed clozapine less than 18 weeks ago
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London, BR3 3BX
About this study
Official title: Investigating Exposure to Toxicants From Smoking and Vaping in People Using Mental Health Services, a Longitudinal Study
Background:
Many people who smoke use vaping products to help them quit. Levels of toxicants in urine samples are substantially lower in those who exclusively vape compared to those who smoke, suggesting that vaping poses only a fraction of the harms as smoking. However, vaping is still not risk free, with some studies finding higher levels of some toxicants among vapers compared to those who do not smoke or vape. People with mental health conditions have different smoking patterns compared with the wider general population. It is not known if people with mental health conditions have different vaping pattens, therefore researchers do not know if they are exposed to different levels of vaping related toxicants. Also, smoking exposes people to high levels of polycyclic aromatic hydrocarbons (PAHs), which can reduce the effectiveness of some psychotropic medication and management of symptoms. Vaping exposes people to lower levels of PAHs than smoking, however it is unknown if the levels of PAHs from vaping affect the metabolization of psychotropic medicines.
Read more
The goal of this observational study is to learn about levels of tobacco toxicants among people with mental health conditions who vape, smoke, dual use or do neither.
The main question[s] it aims to answer are:
What are the levels of biomarkers of toxicant exposure among those who use community mental health services who exclusively vape, exclusively smoke, dual use or do neither, and how do they change over time? What is the difference in clozapine excretion levels and metabolism among those who use community mental health services who exclusively vape, exclusively smoke or dual use or do neither?
Participants will self report smoking and vaping characteristics and provide blood and urine samples at baseline and six months later. Urine will be analysed for tobacco toxicants. Blood will be analysed for levels of clozapine and other prescribed anti psychotic medication.
Researchers will compare levels of toxicants between people who vape, smoke, dual use, or do neither to see if these is a difference.
Read the detailed description
This is a longitudinal observational study. It aims to investigate four groups each with 40 participants (160 in total) and follow them up at 6 months (smokers, vapers and non-users) or 3 months and 6 months (dual users). Participants will complete questionnaires and provide urine and blood samples at each data collection session.
Urine samples will be tested for a range of tobacco toxicants and markers of inflammation and oxidative stress. Blood samples will be tested for levels of clozapine an other anti-psychotic medication.
- Conditions
- Smoking, Tobacco, Vaping, Mental Health Disorder
- Being tested
- Exclusive tobacco smoking, Exclusive e-cigarette use, Dual use of e-cigarettes and tobacco smoking, No use of e-cigarettes or tobacco smoking
- Medical subject headings
- Tobacco Smoking, Vaping, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive tobacco smokingOther
No intervention, participants own tobacco products
Exclusive e-cigarette useOther
No intervention, participants own e-cigarette products
Dual use of e-cigarettes and tobacco smokingOther
No intervention, participants own tobacco and e-cigarette products
No use of e-cigarettes or tobacco smokingOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Smoking | People who smoke tobacco cigarettes at least daily and have not vaped an e-cigarette (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication or other tobacco products for the past 6 months. Receives: Other: Exclusive tobacco smoking | |
| Vaping | People who vape e-cigarettes at least daily and have not smoked tobacco cigarettes (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication, or any other tobacco product for the past 6 months. Receives: Other: Exclusive e-cigarette use | |
| Dual | Dual users (predominant vapers): people who vape e-cigarettes at least daily and also smoke cigarettes at least weekly, and have not used NRT, smoking cessation medication, or any other tobacco product for the past 6 months.
Dual users (predominant smokers): people who smoke tobacco cigarettes at least daily and also vape e-cigarettes at least weekly, and have not used NRT, smoking cessation medication, or any other tobacco product for the past 6 months. Receives: Other: Dual use of e-cigarettes and tobacco smoking | |
| Non-use | People who have neither smoked, vaped, used NRT, smoking cessation medication, nor any other tobacco product for the past 12 months. Receives: Other: No use of e-cigarettes or tobacco smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine
Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine
Measured: Baseline
Nicotine
Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine
Measured: 6 months after baseline
Tobacco-specific nitrosamines
Levels of NNN, NNK(NNAL), NAB, NAT in urine
Measured: Baseline
Tobacco-specific nitrosamines
Levels of NNN, NNK(NNAL), NAB, NAT in urine
Measured: 6 months after baseline
Volatile organic compounds
Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine
Measured: Baseline
Volatile organic compounds
Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine
Measured: 6 months after baseline
Polycyclic aromatic hydrocarbons
Levels of 2-napthol in urine
Measured: Baseline
Polycyclic aromatic hydrocarbons
Levels of 2-napthol in urine
Measured: 6 months after baseline
Metals
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine
Measured: Baseline
Metals
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine
Measured: 6 months after baseline
Secondary outcomes (2)
Clozapine
Levels of clozapine in blood
Measured: Baseline
Clozapine
Levels of clozapine in blood
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953220
- Sponsor's protocol ID
- IRAS: 314314
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Exposure to Toxicants From Smoking and Vaping in People Using Mental Health Services, a Longitudinal Study
- ClinicalTrials.gov ID
- NCT05953220
- Acronym / sponsor ID
- IRAS: 314314
- Conditions
- Smoking, Tobacco, Vaping, Mental Health Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- 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.
Background:
Many people who smoke use vaping products to help them quit. Levels of toxicants in urine samples are substantially lower in those who exclusively vape compared to those who smoke, suggesting that vaping poses only a fraction of the harms as smoking. However, vaping is still not risk free, with some studies finding higher levels of some toxicants among vapers compared to those who do not smoke or vape. People with mental health conditions have different smoking patterns compared with the wider general population. It is not known if people with mental health conditions have different vaping pattens, therefore researchers do not know if they are exposed to different levels of vaping related toxicants. Also, smoking exposes people to high levels of polycyclic aromatic hydrocarbons (PAHs), which can reduce the effectiveness of some psychotropic medication and management of symptoms. Vaping exposes people to lower levels of PAHs than smoking, however it is unknown if the levels of PAHs from vaping affect the metabolization of psychotropic medicines.
The goal of this observational study is to learn about levels of tobacco toxicants among people with mental health conditions who vape, smoke, dual use or do neither.
The main question[s] it aims to answer are:
What are the levels of biomarkers of toxicant exposure among those who use community mental health services who exclusively vape, exclusively smoke, dual use or do neither, and how do they change over time? What is the difference in clozapine excretion levels and metabolism among those who use community mental health services who exclusively vape, exclusively smoke or dual use or do neither?
Participants will self report smoking and vaping characteristics and provide blood and urine samples at baseline and six months later. Urine will be analysed for tobacco toxicants. Blood will be analysed for levels of clozapine and other prescribed anti psychotic medication.
Researchers will compare levels of toxicants between people who vape, smoke, dual use, or do neither to see if these is a difference.
Detailed description
This is a longitudinal observational study. It aims to investigate four groups each with 40 participants (160 in total) and follow them up at 6 months (smokers, vapers and non-users) or 3 months and 6 months (dual users). Participants will complete questionnaires and provide urine and blood samples at each data collection session.
Urine samples will be tested for a range of tobacco toxicants and markers of inflammation and oxidative stress. Blood samples will be tested for levels of clozapine an other anti-psychotic medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smoking | – | Other: Exclusive tobacco smokingPeople who smoke tobacco cigarettes at least daily and have not vaped an e-cigarette (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication or other tobacco products for the past 6 months. |
| Vaping | – | Other: Exclusive e-cigarette usePeople who vape e-cigarettes at least daily and have not smoked tobacco cigarettes (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication, or any other tobacco product for the past 6 months. |
| Dual | – | Other: Dual use of e-cigarettes and tobacco smokingDual users (predominant vapers): people who vape e-cigarettes at least daily and also smoke cigarettes at least weekly, and have not used NRT, smoking cessation medication, or any other tobacco product for the past 6 months. Dual users (predominant smokers): people who smoke tobacco cigarettes at least daily and also vape e-cigarettes at least weekly, and have not used NRT, smoking cessation medication, or any other tobacco product for the past 6 months. |
| Non-use | – | Other: No use of e-cigarettes or tobacco smokingPeople who have neither smoked, vaped, used NRT, smoking cessation medication, nor any other tobacco product for the past 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People from London who use community mental health services
Key inclusion criteria (8 listed)
- People aged 18 and over
- People who use community mental health services (including those who attend clozapine clinics)
- Exclusive smokers - people who smoke tobacco cigarettes at least daily and have not vaped an e-cigarette (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication or other tobacco products for the past 6 months.
- Exclusive vapers- people who vape e-cigarettes at least daily and have not smoked tobacco cigarettes (except one or two puffs on a less than monthly basis), used NRT, smoking cessation medication, or any other tobacco product for the past 6 months.
- Dual users- People who smoke tobacco cigarettes at least daily and also vape e-cigarettes at least once a week, and have not used NRT, smoking cessation medication, nor any other tobacco product for the past 6 months.
Key exclusion criteria (6 listed)
- Under the age of 18 years old.
- Unable to give informed consent.
- Unstable mental state defined as 1) severity of symptoms that render the patient unresponsive, unsociable, uncooperative, aggressive 2) memory impairment from head trauma or impaired ability to sustain concentration. To be assessed by clinical recruiting staff from medical records.
- Taking part in another study, experiment or clinical trial in which there is an intervention to alter their smoking/ vaping behaviour.
- Prescribed antibiotics in the past 14 days (recent infection will skew inflammation marker levels)
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 |
|---|---|---|
| Exclusive tobacco smokingNo intervention, participants own tobacco products | Other | Smoking |
| Exclusive e-cigarette useNo intervention, participants own e-cigarette products | Other | Vaping |
| Dual use of e-cigarettes and tobacco smokingNo intervention, participants own tobacco and e-cigarette products | Other | Dual |
| No use of e-cigarettes or tobacco smokingNo intervention | Other | Non-use |
Primary outcome
Nicotine
Time frame: Baseline
Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine
Nicotine
Time frame: 6 months after baseline
Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine
Tobacco-specific nitrosamines
Time frame: Baseline
Levels of NNN, NNK(NNAL), NAB, NAT in urine
Tobacco-specific nitrosamines
Time frame: 6 months after baseline
Levels of NNN, NNK(NNAL), NAB, NAT in urine
Volatile organic compounds
Time frame: Baseline
Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine
Volatile organic compounds
Time frame: 6 months after baseline
Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine
Polycyclic aromatic hydrocarbons
Time frame: Baseline
Levels of 2-napthol in urine
Polycyclic aromatic hydrocarbons
Time frame: 6 months after baseline
Levels of 2-napthol in urine
Metals
Time frame: Baseline
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine
Metals
Time frame: 6 months after baseline
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine
2 secondary outcomes
Clozapine
Time frame: Baseline
Clozapine
Time frame: 6 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- 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.
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, Tobacco and Vaping, run by King's College 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 8 inclusion and 6 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 20 Jul 2023. 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?
Contact Eve Taylor (+44 (0)20 7836 5454, eve.v.taylor@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine (time frame: Baseline). The study lists 10 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 20 Jul 2023.