An observational study in Smoking, Tobacco, Vaping and Mental Health Disorder, sponsored by King's College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by King's College London · Observational
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's planned enrollment of 160 is below the median of 200 across 480 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People from London who use community mental health services
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.
Exclusion Criteria:
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.
Other: Exclusive tobacco smoking
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.
Other: Exclusive e-cigarette use
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.
Other: Dual use of e-cigarettes and tobacco smoking
People who have neither smoked, vaped, used NRT, smoking cessation medication, nor any other tobacco product for the past 12 months.
Other: No use of e-cigarettes or tobacco smoking
No intervention, participants own tobacco products
No intervention, participants own e-cigarette products
No intervention, participants own tobacco and e-cigarette products
No intervention
Nicotine
Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine
Time frame: Baseline
Nicotine
Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine
Time frame: 6 months after baseline
Tobacco-specific nitrosamines
Levels of NNN, NNK(NNAL), NAB, NAT in urine
Time frame: Baseline
Tobacco-specific nitrosamines
Levels of NNN, NNK(NNAL), NAB, NAT in urine
Time frame: 6 months after baseline
Volatile organic compounds
Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine
Time frame: Baseline
Volatile organic compounds
Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine
Time frame: 6 months after baseline
Polycyclic aromatic hydrocarbons
Levels of 2-napthol in urine
Time frame: Baseline
Polycyclic aromatic hydrocarbons
Levels of 2-napthol in urine
Time frame: 6 months after baseline
Metals
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine
Time frame: Baseline
Metals
Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine
Time frame: 6 months after baseline
Clozapine
Levels of clozapine in blood
Time frame: Baseline
Clozapine
Levels of clozapine in blood
Time frame: 6 months after baseline
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King's College London