Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

Tobacco Dependence Clinical Trial

Official title:

Toxicant Exposure Across Brands of Smokeless Tobacco

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067586
• Other study ID #: 2009NTUC053
• Secondary ID: 1R01CA141531
• Status: Completed
• Start date: February 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The extent of toxicity varies considerably across different brands of smokeless tobacco (ST) products and data suggest that greater toxicity may result in greater health risks. However, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. The goals of this project are to address the following questions:

1. What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior;

2. What are novel and the best measures of smokeless tobacco use, behavior and exposure; and

3. What are some of the determinants of smokeless tobacco use.

Description:

Study 1 is a multi-site descriptive study assessing tobacco toxicants in various smokeless tobacco products and tobacco toxicant exposure found in 600 subjects in three sites: University of MN Twin Cities, Oregon Research Institute in Eugene OR, and at West Virginia University in Morgantown, WV (200 subjects per site). The study will examine the relationship between brands of U.S. smokeless tobacco products that contain different levels of tobacco-specific nitrosamines (TSNAs), other carcinogens and nicotine, and biomarkers of exposure and effects on health (e.g., cardiovascular risk factors). Additionally, the study will examine factors that influence the extent of toxicant exposure and effect besides the levels of toxicants in the product. Subjects will attend an orientation where they will sign a consent form and then return for one clinic visit where they will provide blood (UMN only), urine samples, buccal samples and expectorated chews to be examined for nicotine levels, toxicant exposure and potential for tobacco-related health risks. A subsample of subjects (10 per brand of smokeless tobacco) will be asked for a tin of their unused product for testing (they will be reimbursed for the cost of their tin) and will be asked for three samples of expectorated chews that will be collected, frozen and shipped to the CDC where they will be analyzed for tobacco constituents. Subjects will complete several questionnaires on their tobacco use history, alcohol, diet, physical and mental health. Subjects will also keep a daily diary of their tobacco and alcohol use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Using a consistent and daily amount of ST for the past year;

2. In good physical health (no unstable medical condition);

3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

1. Subjects must not be currently using other tobacco or nicotine products.

2. Female subjects cannot be pregnant or nursing.

Related Conditions & MeSH terms

• Smokeless Tobacco Use
• Tobacco Dependence
• Tobacco Use Disorder

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	University of MN's Tobacco Use Research Center	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands	Two important harmful constituents in smokeless tobacco products are NNN + NNK, µg/g This measure reports the tobacco-specific nitrosamines (TSNA), N'-nitrosonornicotine (NNN), and 4- (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) across 7 different smokeless tobacco brands.	Three "usual" dip sized samples were collected from subjects at baseline