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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953220
• Other study ID #: IRAS: 314314
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: King's College London
• Contact: Eve Taylor
• Phone: +44 (0)20 7836 5454
• Email: eve.v.taylor[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• People aged 18 and over

• People who use community mental health services (including those who attend clozapine clinics)

And one of the 4 categories:

• Exclusive smokers - 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.

• Exclusive vapers- 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 users- People who smoke tobacco cigarettes at least daily and also vape e-cigarettes at least once a week, and have not used NRT, smoking cessation medication, nor any other tobacco product for the past 6 months.

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:

• Under the age of 18 years old.

• Unable to give informed consent.

• Unstable mental state defined as 1) severity of symptoms that render the patient unresponsive, unsociable, uncooperative, aggressive 2) memory impairment from head trauma or impaired ability to sustain concentration. To be assessed by clinical recruiting staff from medical records.

• Taking part in another study, experiment or clinical trial in which there is an intervention to alter their smoking/ vaping behaviour.

• Prescribed antibiotics in the past 14 days (recent infection will skew inflammation marker levels)

• Prescribed clozapine less than 18 weeks ago

Related Conditions & MeSH terms

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

Intervention

Other:
• Exclusive tobacco smoking
No intervention, participants own tobacco products
• Exclusive e-cigarette use
No intervention, participants own e-cigarette products
• Dual use of e-cigarettes and tobacco smoking
No intervention, participants own tobacco and e-cigarette products
• No use of e-cigarettes or tobacco smoking
No intervention

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nicotine	Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine	Baseline
Primary	Nicotine	Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine	6 months after baseline
Primary	Tobacco-specific nitrosamines	Levels of NNN, NNK(NNAL), NAB, NAT in urine	Baseline
Primary	Tobacco-specific nitrosamines	Levels of NNN, NNK(NNAL), NAB, NAT in urine	6 months after baseline
Primary	Volatile organic compounds	Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine	Baseline
Primary	Volatile organic compounds	Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine	6 months after baseline
Primary	Polycyclic aromatic hydrocarbons	Levels of 2-napthol in urine	Baseline
Primary	Polycyclic aromatic hydrocarbons	Levels of 2-napthol in urine	6 months after baseline
Primary	Metals	Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine	Baseline
Primary	Metals	Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine	6 months after baseline
Secondary	Clozapine	Levels of clozapine in blood	Baseline
Secondary	Clozapine	Levels of clozapine in blood	6 months after baseline