Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use
18 Years
N/A
Both
Tobacco Use Disorder, Nicotine Dependence
Trial Information
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use
Study design dependent on results from Study 1.
Inclusion Criteria:
1. Using a consistent and daily amount of ST with specific nicotine and tobacco-specific
nitrosamine (TSNA) levels 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1. To determine if switching to ST products with reduced toxicant levels will result in reduction of biomarkers of exposure and toxicity. 2. To determine the nicotine levels of ST that would lead to the greatest reduction in tobacco toxicant exposure.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Dorothy Hatsukami, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Minnesota - Clinical and Translational Science Institute
Authority:
United States: Federal Government
Study ID:
1R01CA141531-01
NCT ID:
NCT01067599
Start Date:
April 2011
Completion Date:
August 2014
Related Keywords:
- Tobacco Use Disorder
- Nicotine Dependence
- Biomarkers of tobacco exposure
- Smokeless Tobacco
- Tobacco Use Disorder
Name | Location |
|---|---|
| Oregon Research Institute | Eugene, Oregon 97403 |
