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Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

NCT ID: NCT01067586

Last Updated: 2022-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Smokeless Tobacco Use Tobacco Dependence

Keywords

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Smokeless Tobacco Biomarkers of tobacco exposure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dorothy Hatsukami, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of MN's Tobacco Use Research Center

Minneapolis, Minnesota, United States

Site Status

Oregon Research Institute

Eugene, Oregon, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01CA141531

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009NTUC053

Identifier Type: -

Identifier Source: org_study_id