Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Recruitment status was Recruiting
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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:
- What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior;
- What are novel and the best measures of smokeless tobacco use, behavior and exposure; and
- 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 |
- Extent of toxicity across 6 brands of smokeless tobacco [ Time Frame: Baseline only ] [ Designated as safety issue: No ]
- 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.
| Estimated Enrollment: | 600 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | December 2011 (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 |
Smokeless tobacco users of 6 brands of tobacco
Inclusion Criteria:
- Using a consistent and daily amount of ST for the past year;
- In good physical health (no unstable medical condition);
- 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:
- Subjects must not be currently using other tobacco or nicotine products.
- Female subjects cannot be pregnant or nursing.
Contacts and Locations| Contact: Joni Jensen, MPH | 612-624-5178 | jense010@umn.edu |
| United States, Minnesota | |
| University of MN's Tobacco Use Research Center | Recruiting |
| Minneapolis, Minnesota, United States, 55414 | |
| Contact: Joni Jensen, MPH 612-624-5178 jense010@umn.edu | |
| Contact: Rachel Nyboer, BA 612624-4983 nyboe001@umn.edu | |
| Principal Investigator: Dorothy Hatsukami, PhD | |
| United States, Oregon | |
| Oregon Research Institute | Active, not recruiting |
| Eugene, Oregon, United States, 97403 | |
| United States, West Virginia | |
| West Virginia University | Active, not recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Principal Investigator: | Dorothy Hatsukami, PhD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Dorothy Hatsukami, Ph.D., University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01067586 History of Changes |
| Other Study ID Numbers: | 1R01CA141531, 1R01CA141531 |
| Study First Received: | February 10, 2010 |
| Last Updated: | February 10, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Smokeless Tobacco Biomarkers of tobacco exposure |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Lobeline Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013