Persistence of Oral DNA Adducts in Smokers and Vapers

NCT ID: NCT06983392

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2030-07-30

Brief Summary

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.

Detailed 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.

Conditions

Smokers; Vaping; Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study group

Abstain from product use (either smoking cigarettes or vaping)

Group Type: EXPERIMENTAL

Abstain from smoking/vaping

Intervention Type: BEHAVIORAL

They may be asked to stop smoking cigarettes or vaping during the study for 21 days. If they are asked to abstain from their product use they will be given nicotine patches and/or lozenges to help with abstinence during the study.

Interventions

Abstain from smoking/vaping

They may be asked to stop smoking cigarettes or vaping during the study for 21 days. If they are asked to abstain from their product use they will be given nicotine patches and/or lozenges to help with abstinence during the study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Hecht

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Central Contacts

Laura Maertens

Role: CONTACT

maert006@umn.edu

612-626-8654

Other Identifiers

2025LS003

Identifier Type: -

Identifier Source: org_study_id