Clinical Trial

Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

Active, Not Recruiting Phase 1
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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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2019-06-24; most recent amendment 2025-11-21.
Status change: Suspended → Active, Not Recruiting 2025-11-21
Status change: Recruiting → Suspended 2025-04-11
Status change: Not Yet Recruiting → Recruiting 2021-10-19
Trial Details
NCT Number NCT03998735
Lead Sponsor Masonic Cancer Center, University of Minnesota
Collaborators: National Institutes of Health (NIH)
Conditions Smokeless Tobacco
Enrollment 55 participants
Start Date 2021-10-19
Primary Completion 2025-08-01 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-11-26