Deuterated NNN for Tobacco Exposure

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

Must not be taking: Metabolic enzyme medications

Disqualifiers: Other tobacco, Unstable medical, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults in good physical and mental health who regularly use smokeless tobacco. They must not be pregnant, nursing, or planning pregnancy soon. Participants should not be on medications affecting metabolism enzymes, using other tobacco products, or have unstable medical conditions.

Inclusion Criteria

I am willing to give blood, saliva, and urine samples and visit the clinic multiple times.

I am in good health with no serious or unstable conditions.

You use smokeless tobacco products regularly.

Exclusion Criteria

You are not willing to switch to a specific type of tobacco that contains a certain chemical called [pyridine-D4](S)-NNN for the duration of the study.

I am on medication that affects my metabolism.

My health condition changes rapidly and unpredictably.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phone screening and 1 in-person orientation visit

Baseline

Participants attend a baseline visit to receive the smokeless tobacco product and instructions for use

1 week

1 in-person visit

Treatment

Participants use the smokeless tobacco study product containing deuterated NNN and collect samples for analysis

1 week

3 lab sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Deuterated NNN

Trial Overview The study tests how a toxin called N'-nitrosonornicotine (NNN) found in smokeless tobacco is broken down by users. It involves giving participants a special version of this toxin labeled with deuterium to track its breakdown in the body through blood, saliva, cheek cells, and urine samples.

Participant Groups

Group I: Smokeless tobacco study product Experimental Treatment 1 Intervention

Smokeless tobacco product spiked with deuterated NNN.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+