Metabolism of Deuterated NNN in Smokeless Tobacco Users

NCT02414477 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 2014NTLS110
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand how people break down a tobacco specific cancer-causing toxin called N'-nitrosonornicotine (NNN) that is present in smokeless tobacco and cigarettes. Some people are able to get rid of this chemical as a harmless agent better than others. Through this research, the investigators hope to develop a better understanding of how people process potentially harmful chemicals and identify tobacco users who are in danger of developing cancer. Participants will complete questionnaires regarding their health and smoking history. The investigators will take blood samples, saliva samples, cheek cells and urine to measure exposure to toxins and harmful chemicals present in smokeless tobacco. Participants will be given smokeless tobacco study product and be asked to use only it for the entire time they are in the study. The study product contains deuterated NNN. Deuterated NNN is just like the NNN found in commercially available smokeless tobacco products, but is labeled with deuterium or heavy hydrogen atoms. Deuterium is non-toxic and safe. Using smokeless tobacco containing deuterium allows us to follow NNN as it is broken down in the body.

Conditions

Tobacco Toxicant Exposure

Keywords

tobacco toxicants; smokeless tobacco; nitrosamines; tobacco specific nitrosamines (TSNAs)

Outcome Measures

Primary Outcomes (1)

• Determine extent of α-hydroxylation of NNN as indicated by presence of keto acid 17 and hydroxy acid 22 in plasma

  Deuterated NNN will be assessed after one week of regular use via smokeless tobacco study product, as well as during use in three lab sessions.

  One week post dosing

Study Arms (1)

Smokeless tobacco study product

EXPERIMENTAL

Smokeless tobacco product spiked with deuterated NNN.

Drug: Deuterated NNN

Interventions

Deuterated NNN DRUG

Smokeless tobacco study product

Smokeless tobacco study product

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular smokeless tobacco user
• Good physical health with no unstable medical conditions
• Stable and good mental health, i.e., currently do not experience unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria, during the past six months
• Willing to perform study activities such as having blood sample drawn, saliva collection, urine collection, multiple clinic visits
• For female subjects of child bearing potential, not known to be pregnant or nursing, or planning to become pregnant within next 12 months
• Provide written informed consent

You may not qualify if:

• Using other tobacco or nicotine containing products
• Unstable medical condition
• Currently taking any medications that affect relevant metabolic enzymes
• Not willing to use switch smokeless tobacco brand to use tobacco enriched with \[pyridine-D4\](S)-NNN for the course of this study

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

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MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 10, 2015
• Study Start: April 15, 2018
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

US (1)