Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

NCT01067586 | Completed Results DMC

• 2 other identifiers: 2009NTUC0531R01CA141531
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 3

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. 1.What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior;
2. 2.What are novel and the best measures of smokeless tobacco use, behavior and exposure; and
3. 3.What are some of the determinants of smokeless tobacco use.

Conditions

Smokeless Tobacco Use; Tobacco Dependence

Keywords

Smokeless Tobacco; Biomarkers of tobacco exposure

Outcome Measures

Primary Outcomes (1)

• Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands

  Two important harmful constituents in smokeless tobacco products are NNN + NNK, µg/g This measure reports the tobacco-specific nitrosamines (TSNA), N'-nitrosonornicotine (NNN), and 4- (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) across 7 different smokeless tobacco brands.

  Three "usual" dip sized samples were collected from subjects at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Smokeless tobacco users of 6 brands of tobacco

You may qualify if:

• 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).

You may not qualify if:

• Subjects must not be currently using other tobacco or nicotine products.
• Female subjects cannot be pregnant or nursing.

Sponsors & Collaborators

• University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of MN's Tobacco Use Research Center

Minneapolis, Minnesota, 55414, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dorothy Hatsukami, PhD
• Organization: University of Minnesota

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Locations

US (3)