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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Non-use | People who have neither smoked, vaped, used NRT, smoking cessation medication, nor any other tobacco product for the past 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exclusive tobacco smoking | Other | No intervention, participants own tobacco products |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine | Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine | Baseline |
| Nicotine | Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine | 6 months after baseline |
| Tobacco-specific nitrosamines | Levels of NNN, NNK(NNAL), NAB, NAT in urine | Baseline |
| Tobacco-specific nitrosamines | Levels of NNN, NNK(NNAL), NAB, NAT in urine | 6 months after baseline |
| Volatile organic compounds | Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine | Baseline |
| Volatile organic compounds | Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine | 6 months after baseline |
| Polycyclic aromatic hydrocarbons | Levels of 2-napthol in urine | Baseline |
| Polycyclic aromatic hydrocarbons | Levels of 2-napthol in urine | 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Clozapine | Levels of clozapine in blood | Baseline |
| Clozapine | Levels of clozapine in blood | 6 months after baseline |
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Inclusion Criteria:
And one of the 4 categories:
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.
Exclusion Criteria:
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People from London who use community mental health services
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eve Taylor | Contact | +44 (0)20 7836 5454 | eve.v.taylor@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley NHS Foundation Trust | London | BR3 3BX | United Kingdom |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D000072137 | Vaping |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Urine and blood samples will be collected at baseline and 6 months for people who smoke, vape or do neither. They be collected at baseline, 3 months and 6 month for people who dual use.
| Exclusive e-cigarette use |
| Other |
No intervention, participants own e-cigarette products |
|
| Dual use of e-cigarettes and tobacco smoking | Other | No intervention, participants own tobacco and e-cigarette products |
|
| No use of e-cigarettes or tobacco smoking | Other | No intervention |
|
| Metals |
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine |
| Baseline |
| Metals | Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine | 6 months after baseline |