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NCT02414477 · ClinicalTrials.gov registry record · Phase 1
Metabolism of Deuterated NNN in Smokeless Tobacco Users
A Phase 1 study, sponsored by University of Minnesota.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02414477 is a Phase 1 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 13 participants.
The verdict
NCT02414477, a Phase 1 study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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.
Interventions
- DRUG Deuterated NNN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-04-15 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02414477
The ClinicalTrials.gov registry entry for NCT02414477 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Deuterated NNN is the first listed.
NCT02414477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02414477 about?
NCT02414477 is a clinical study titled "Metabolism of Deuterated NNN in Smokeless Tobacco Users". 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 thi...
What is the current status of trial NCT02414477?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2018-04-15. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT02414477?
The interventions under investigation include: Deuterated NNN (DRUG).
Who is sponsoring clinical trial NCT02414477?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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