e-Cigarette - DNA Adducts

Smoking Clinical Trial

Official title:

e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284632
• Other study ID #: 2017NTLS040
• Status: Completed
• Start date: July 11, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.

Description:

In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months.

At these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection.

Subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health;

Meet criteria for 1 of three groups:

1. Regular smokers confirmed by CO;

2. E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users

3. Non-smokers

Exclusion Criteria:

• Unstable medical condition Not willing to attend visits

Related Conditions & MeSH terms

• Cigarette Smoking
• Electronic Cigarettes
• Smoking

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA Adducts	Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping	6 months
Secondary	Urinary 8-iso-PGF-2a	Stability of Urinary 8-iso-PGF-2a (biomarkers of oxidative damage) over a 6-month sample period	6 months
Secondary	Urinary PGEM	Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period	6 months
Secondary	C-reactive protein	Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period	6 months
Secondary	TNE	Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period	6 months