Clinical trial NCT01067586: Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Official title: Toxicant Exposure Across Brands of Smokeless Tobacco
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smokeless Tobacco Use
Tobacco Dependence
Keywords: Smokeless Tobacco
Biomarkers of tobacco exposure
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-11
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smokeless tobacco users of 6 brands of tobacco

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands
timeFrame: Three "usual" dip sized samples were collected from subjects at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of MN's Tobacco Use Research Center
state: Minnesota
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PhD
role: PRINCIPAL_INVESTIGATOR
References: