Investigating Exposure to Toxicants From Smoking and Vaping

Mental Health Disorder Clinical Trial

Official title: Investigating Exposure to Toxicants From Smoking and Vaping in People Using Mental Health Services, a Longitudinal Study

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Smoking, Tobacco
• Vaping

• NCT number: NCT05953220
• Study type: Observational
• Source: King's College London
• Contact: Eve Taylor
• Phone: +44 (0)20 7836 5454
• Email: eve.v.taylor@kcl.ac.uk
• Status: Not yet recruiting
• Start date: August 2023
• Completion date: January 2025