Tobacco Toxicant Exposure Clinical Trial
Official title:
Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
The purpose of this research study is to better understand how people respond to cancer-causing chemicals in cigarette smoke. Some people are able to get rid of these chemicals as harmless agents while others suffer damage to their cells that can ultimately result in cancer. We hope to develop a better understanding of how we can identify the people who are in danger of getting cancer. Participants will complete questionnaires regarding their health and smoking history. We will take blood samples to look at genes which determine how the body breaks down some tobacco-related toxins. Participants will be given a small amount of liquid to drink, containing alcohol, water, and a compound called deuterated phenanthrene (DP), which is found in cigarette smoke and in the environment. Phenanthrene is non-toxic and does not cause cancer, but this compound is broken down by the body in the same way as cancer-causing agents. We will follow the pathway of this compound as it is broken down in the body.
Forty apparently healthy smokers and non smokers (20 male, 20 female) will be recruited by
advertising in the Twin Cities area. This will be done by the Tobacco Use Research Center.
They will be screened in a phone call, then invited to come in for an orientation session at
which consent will be obtained. Pregnant smokers will be excluded. They will visit the
clinic weekly for 2 months and once monthly for 4 months for a total of 6 months
participation.
At each visit they will drink 5 ml of 50:50 ethanol:water containing 10 ug
[D10]phenanthrene. They will then collect their 24h urine and return it to the clinic. The
urine will be analyzed for [D10]phenanthrene tetraol. The goal of the study is to determine
the longitudinal stability of the amount of [D10]phenanthrene-tetraol in urine.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02414477 -
Metabolism of Deuterated NNN in Smokeless Tobacco Users
|
Phase 1 |