Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05953220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-20
First Post:
2023-05-02
Brief Title:
Investigating Exposure to Toxicants From Smoking and Vaping
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Investigating Exposure to Toxicants From Smoking and Vaping in People Using Mental Health Services a Longitudinal Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 questions 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
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 questions 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None