Persistence of Oral DNA Adducts in Smokers and Vapers

Not Applicable

Not yet recruiting

• Conditions: Smokers; Vaping; Healthy Volunteers

• Registration Number: NCT06983392
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2025-04-14
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-07-30
• Primary Completion: 2029-07-30
• Study Completion: 2030-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oral DNA damage (adduct) levels	DNA damage will be assessed at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use	The levels and types of DNA damage (adducts) will be measured in the oral cells of all participants. DNA adducts will be reported as fmol/umol dG or as # adducts / 10\^8 nucleotides.; DNA adduct levels will be compared between those who continue to use their products, those who stop using their products, and those who never use tobacco or nicotine products.; The goal is to identify DNA 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 DNA damage.
Urinary smoking markers	Urine levels will be measured at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use.	Total nicotine equivalents (TNE), cyanoethyl mercapturic acid (CEMA), and NNAL will be measured in the urine of participants to confirm if they smoked during the study. The concentration of these compounds will be reported at pmol/mL urine

Secondary Outcome Measures

Name	Time	Method
Urinary vape markers	Vaping markers will be measured in the urine at baseline and Days 3, 6, 12 and 21 after stopping or continuing use.	Propylene glycol and glycerol will be measured in the urine of participants to confirm if they vaped during the study. The concentration of these compounds will be reported as pmol/mL urine.