Investigating Exposure to Toxicants From Smoking and Vaping

NCT05953220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

  • Smoking, Tobacco
  • Vaping
  • Mental Health Disorder

Interventions

OTHER

Exclusive tobacco smoking

No intervention, participants own tobacco products

OTHER

Exclusive e-cigarette use

No intervention, participants own e-cigarette products

OTHER

Dual use of e-cigarettes and tobacco smoking

No intervention, participants own tobacco and e-cigarette products

OTHER

No use of e-cigarettes or tobacco smoking

No intervention

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-08-31
Completion
2025-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05953220 on ClinicalTrials.gov