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Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use


Phase 2
18 Years
N/A
Not Enrolling
Both
Tobacco Use Disorder, Nicotine Dependence

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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 InstituteEugene, Oregon  97403