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Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01067586
First received: February 10, 2010
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.

Condition
Smokeless Tobacco Use
Tobacco Dependence

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Toxicant Exposure Across Brands of Smokeless Tobacco

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Extent of toxicity across 6 brands of smokeless tobacco [ Time Frame: Baseline only ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Testing novel and best measures to assess level of smokeless tobacco use behavior and exposure. [ Time Frame: Baseline and history ] [ Designated as safety issue: No ]
  • What are some of the determinants of smokeless tobacco use. [ Time Frame: Baseline and history ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine, buccal cells and blood will be collected from subjects in this study.


Enrollment: 340
Study Start Date: February 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Brand: Copenhagen
Brand: Kodiak
Brand: Grizzly
Brand: Skoal
Brand: Timber Wolf
Brand: Skoal Bandits

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Smokeless tobacco users of 6 brands of tobacco

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067586

Locations
United States, Minnesota
University of MN's Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55414
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01067586     History of Changes
Other Study ID Numbers: 1R01CA141531, 1R01CA141531
Study First Received: February 10, 2010
Last Updated: October 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Smokeless Tobacco
Biomarkers of tobacco exposure

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 24, 2014