drugset / Trial / NCT02414477

Metabolism of Deuterated NNN in Smokeless Tobacco Users

NCT02414477 ↗

Phase 1 Terminated 13 enrolled University of Minnesota
NaSingle-groupOpen-labelBasic science

Summary

The purpose of this study is to better understand how people break down a tobacco specific cancer-causing toxin called N'-nitrosonornicotine (NNN) that is present in smokeless tobacco and cigarettes. Some people are able to get rid of this chemical as a harmless agent better than others. Through this research, the investigators hope to develop a better understanding of how people process potentially harmful chemicals and identify tobacco users who are in danger of developing cancer. Participants will complete questionnaires regarding their health and smoking history. The investigators will take blood samples, saliva samples, cheek cells and urine to measure exposure to toxins and harmful chemicals present in smokeless tobacco. Participants will be given smokeless tobacco study product and be asked to use only it for the entire time they are in the study. The study product contains deuterated NNN. Deuterated NNN is just like the NNN found in commercially available smokeless tobacco products, but is labeled with deuterium or heavy hydrogen atoms. Deuterium is non-toxic and safe. Using smokeless tobacco containing deuterium allows us to follow NNN as it is broken down in the body.

Timeline

Start
2018-04-15
Primary completion
2020-02-21
Completion
2020-02-21

Outcome

Outcome not reported

Stopped: “not successful in securing the deuterated products”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Deuterated NNN Unknown — —

Indications

No indication recorded.