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Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

NCT03998735 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-11-26

No results posted yet for this 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

  • Smokeless Tobacco

Interventions

DRUG

Herbal Snuff (Smokeless Tobacco)

4 levels of \[D4\]nornicotine in herbal snuff

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Irina Stepanov, PhD · University of Minnesota, Division of Environmental Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2025-08-01
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998735 on ClinicalTrials.gov