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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Abstain from product use (either smoking cigarettes or vaping) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abstain from smoking/vaping | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral DNA damage (adduct) levels | 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. | DNA damage will be assessed at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use |
| Urinary smoking markers | 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 | Urine levels will be measured at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary vape markers | 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. | Vaping markers will be measured in the urine at baseline and Days 3, 6, 12 and 21 after stopping or continuing use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Hecht | University of Minnesota | Principal Investigator |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Participants will be asked to fill out study questionnaires and attend six in-person study visits to provide saliva, mouth cells, cheek cells, and urine. They will not be able to eat or drink anything other than water for at least 1 hour before your study visits.
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.
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