Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998735
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Smokeless Tobacco Drug: Herbal Snuff (Smokeless Tobacco) Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group 1 (N=15)
160 µg/g herbal snuff, median level found in commercial moist snuff
 Drug: Herbal Snuff (Smokeless Tobacco)
4 levels of [D4]nornicotine in herbal snuff
Experimental: Group 2 (N=15)
70 µg/g herbal snuff, lowest level found in commercial moist snuff (rounded)
 Drug: Herbal Snuff (Smokeless Tobacco)
4 levels of [D4]nornicotine in herbal snuff
Experimental: Group 3 (N=15)
3.5 µg/g herbal snuff, 5% of the lowest level found in commercial moist snuff
 Drug: Herbal Snuff (Smokeless Tobacco)
4 levels of [D4]nornicotine in herbal snuff
Active Comparator: Group 4(N=10)
0 µg/g herbal snuff, control group will use unmodified herbal snuff
 Drug: Herbal Snuff (Smokeless Tobacco)
4 levels of [D4]nornicotine in herbal snuff


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To investigate endogenous formation of NNN in smokeless tobacco users. [ Time Frame: 2 Weeks ]
    Presence of urinary [pyridine-D4]NNN ([D4]NNN)

  2. To investigate endogenous formation of NNN in smokeless tobacco users. [ Time Frame: 2 Weeks ]
    Level of urinary [pyridine-D4]NNN ([D4]NNN) present


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female adult smokeless tobacco users 18-65 years of age, using at least 3 tins of product per week for 6 months;
  • Used the same brand for >80% of their smokeless tobacco use over the course of at least 6 months, and used this brand exclusively for at least two weeks prior to the eligibility screening;
  • Not smoking or using any other nicotine or tobacco product in the past 2 weeks (expired CO < 6 ppm);
  • Participants are in good physical health (no unstable medical condition) and good general oral health as determined by the licensed medical professional;
  • Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse) as determined by the licensed medical professional;
  • Participants who are not taking any medications that affect relevant metabolic enzymes;
  • Women who are not pregnant or nursing or planning to become pregnant;
  • Participants have provided written informed consent to participate in the study.

Exclusion Criteria:

  • Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional;
  • Vital signs out of range as determined by the licensed medical professional (participants failing for vital signs will be allowed to re-screen once):
  • Evident poor oral health (significant gum recession, dental caries, tooth loss) as determined by the general oral health status check;
  • Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
  • Regular smoking or tobacco use (e.g., greater than once a week) other than oral smokeless tobacco products;
  • Currently (within the past 2 weeks) using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998735


Contacts
Layout table for location contacts
Contact: Hanna Vanderloo, RN, MSN 612-624-4983 hannav@umn.edu

Locations
Layout table for location information
United States, Minnesota
Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55411
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Irina Stepanov, PhD University of Minnesota, Division of Environmental Health Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03998735    
Obsolete Identifiers: NCT02499198
Other Study ID Numbers: SPH-2019-23251
2019NTLS123 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents