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Persistence of Oral DNA Adducts in Smokers and Vapers

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Begins enrollment in 1 month

Conditions

Healthy Volunteers
Smokers
Vaping

Treatments

Behavioral: Abstain from smoking/vaping

Study type

Interventional

Funder types

Other

Identifiers

NCT06983392
2025LS003

Details and patient eligibility

About

This study aims to better understand what damage caused to oral cells from smoking and vaping might be important in the formation of oral cancers. We will compare levels of DNA damage between those asked to stop smoking or vaping to those who continue to smoke or vape and those who never use tobacco or nicotine products. The goal is to identify damage that is found at higher levels or remains in the oral cells longer because they might be more important in causing cancer than other types of damage.

Full description

DNA damage (adducts) in the oral cells will be measured in people who smoke and vape while they are using their products regularly for two weeks. Then half of the participants will be asked to stop smoking or vaping. Biological samples (saliva, urine, mouth cells, and cheek cells) will be collected at 6 visits to determine how DNA damage changes in the mouth cells of people asked to stop using their products to those who continue to use their product. The DNA damage in these groups will also be compared to those who do not use tobacco or nicotine products at all. It is believed that DNA damage that remains in the cells longer or that is at higher levels than other DNA damage might be more important to cancer formation.

Enrollment

150 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 21+ years old
  • Good physical and mental health
  • Stable physical and mental health
  • Either 1) smokes cigarettes daily, 2) vapes daily, 3) does not use any tobacco or nicotine products

Exclusion criteria

  • Pregnant or nursing
  • High blood pressure
  • Unstable health condition(s)
  • History of cancer or liver disease

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Study group
Experimental group
Description:
Abstain from product use (either smoking cigarettes or vaping)
Treatment:
Behavioral: Abstain from smoking/vaping

Trial contacts and locations

0

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Central trial contact

Laura Maertens

Data sourced from clinicaltrials.gov

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