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NCT03998735 · ClinicalTrials.gov registry record · Phase 1
Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure
A Phase 1 study of Smokeless Tobacco, sponsored by Masonic Cancer Center, University of Minnesota.
- Active
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03998735 is a Phase 1 study of Smokeless Tobacco that is active but no longer recruiting, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 55 participants, below the 225-participant average among 3 other Smokeless Tobacco trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03998735, a Phase 1 study of Smokeless Tobacco, is active but no longer recruiting, sponsored by Masonic Cancer Center, University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Our goal in this study is to investigate the extent of endogenous nitrosation of nornicotine in smokeless tobacco users as a function of nornicotine content in smokeless products. This study will lead to an understanding of the endogenous formation of NNN from nornicotine in humans, and will also investigate the effect of the reduction of nornicotine content in smokeless tobacco on the extent of endogenous NNN formation. The knowledge gained in this study will lead to the development of recommendations for the regulation, or potentially elimination, of nornicotine in smokeless tobacco products in order to minimize exposure to NNN in the users of these products.
Conditions Studied
Interventions
- DRUG Herbal Snuff (Smokeless Tobacco)
Study Locations (1)
Minnesota
- Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03998735
The ClinicalTrials.gov registry entry for NCT03998735 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 225-participant average among 3 other Smokeless Tobacco trials with a reported enrollment target (76% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Smokeless Tobacco appearing as the primary indexed condition, and to 1 intervention - of which Herbal Snuff (Smokeless Tobacco) is the first listed.
NCT03998735 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT03998735 about?
NCT03998735 is a clinical study titled "Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure". Our goal in this study is to investigate the extent of endogenous nitrosation of nornicotine in smokeless tobacco users as a function of nornicotine content in smokeless products. This study will lead to an understanding of the endogenous formation of NNN from nornicotine in humans, and will also in...
What is the current status of trial NCT03998735?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-10-19. Estimated completion is 2026-08.
What conditions does trial NCT03998735 study?
This clinical trial studies the following conditions: Smokeless Tobacco.
What interventions are being tested in trial NCT03998735?
The interventions under investigation include: Herbal Snuff (Smokeless Tobacco) (DRUG).
Who is sponsoring clinical trial NCT03998735?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03998735 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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