Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067586
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : December 15, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease
Smokeless Tobacco Use Tobacco Dependence

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.

Study Type : Observational
Actual Enrollment : 359 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Toxicant Exposure Across Brands of Smokeless Tobacco
Study Start Date : February 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Extent of toxicity across 6 brands of smokeless tobacco [ Time Frame: Baseline only ]

Secondary Outcome Measures :
  1. Testing novel and best measures to assess level of smokeless tobacco use behavior and exposure. [ Time Frame: Baseline and history ]
  2. What are some of the determinants of smokeless tobacco use. [ Time Frame: Baseline and history ]

Biospecimen Retention:   Samples Without DNA
Urine, buccal cells and blood will be collected from subjects in this study.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Smokeless tobacco users of 6 brands of tobacco

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067586

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
National Cancer Institute (NCI)
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT01067586     History of Changes
Other Study ID Numbers: 2009NTUC053
1R01CA141531 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents