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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

February 10, 2010
October 17, 2013
February 2010
April 2013   (final data collection date for primary outcome measure)
Extent of toxicity across 6 brands of smokeless tobacco [ Time Frame: Baseline only ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01067586 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Toxicant Exposure Across Brands of Smokeless Tobacco

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

Smokeless tobacco users of 6 brands of tobacco

  • Smokeless Tobacco Use
  • Tobacco Dependence
Not Provided
  • Brand: Copenhagen
  • Brand: Kodiak
  • Brand: Grizzly
  • Brand: Skoal
  • Brand: Timber Wolf
  • Brand: Skoal Bandits
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01067586
1R01CA141531, 1R01CA141531
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • National Institute on Drug Abuse (NIDA)
  • National Cancer Institute (NCI)
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP