NCT03998735

Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Smokeless Tobacco

Interventions

Type	Name	Description
DRUG	Herbal Snuff (Smokeless Tobacco)	4 levels of \[D4\]nornicotine in herbal snuff

Timeline

• Start date: 2021-10-19
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2019-06-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study