Investigating Exposure to Toxicants From Smoking and Vaping

NCT05953220 | Unknown

• 1 other identifier: IRAS: 314314
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (10)

• Nicotine

  Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine

  Baseline

• Nicotine

  Levels of nicotine and its metabolites (nicotine, 3-hydroxycotinine) in urine

  6 months after baseline

• Tobacco-specific nitrosamines

  Levels of NNN, NNK(NNAL), NAB, NAT in urine

  Baseline

• Tobacco-specific nitrosamines

  Levels of NNN, NNK(NNAL), NAB, NAT in urine

  6 months after baseline

• Volatile organic compounds

  Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine

  Baseline

• Volatile organic compounds

  Levels of Acrolein, Acrylamide, Acrylonitrile, Benzene and Crotonaldehyde in urine

  6 months after baseline

• Polycyclic aromatic hydrocarbons

  Levels of 2-napthol in urine

  Baseline

• Polycyclic aromatic hydrocarbons

  Levels of 2-napthol in urine

  6 months after baseline

• Metals

  Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine

  Baseline

• Metals

  Levels of Cadmium, Lead, Mercury, Nickle, Selenium in urine

  6 months after baseline

Secondary Outcomes (2)

• Clozapine

  Baseline

• Clozapine

  6 months after baseline

Study Arms (4)

Smoking

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

Vaping

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

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

Non-use

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

Interventions

Exclusive tobacco smoking OTHER

No intervention, participants own tobacco products

Smoking

Exclusive e-cigarette use OTHER

No intervention, participants own e-cigarette products

Vaping

Dual use of e-cigarettes and tobacco smoking OTHER

No intervention, participants own tobacco and e-cigarette products

Dual

No use of e-cigarettes or tobacco smoking OTHER

No intervention

Non-use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People from London who use community mental health services

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, BR3 3BX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples will be collected at baseline and 6 months for people who smoke, vape or do neither. They be collected at baseline, 3 months and 6 month for people who dual use.

MeSH Terms

Conditions

Tobacco Smoking; Vaping; Mental Disorders

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Eve Taylor

CONTACT

+44 (0)20 7836 5454; eve.v.taylor@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: July 20, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)