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Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Smoking Cessation and Among Non-abstainers, for Reduction in Cigarette Smoking


Phase 2
18 Years
70 Years
Not Enrolling
Both
Tobacco Use Disorder

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Trial Information

Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Smoking Cessation and Among Non-abstainers, for Reduction in Cigarette Smoking


This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical
trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to
be most popular in Study 1 or to nicotine gum for 12 weeks to compare efficacy for smoking
cessation. The secondary aims are to determine the effects of the products on biomarkers of
exposure and toxicity. If the sample size is sufficient, then comparisons will be made
across products on these measures while controlling for amount of tobacco use. Other
secondary aims include examining the reliability of our biological measures in a control
group that continues to smoke, the extent of constituent extraction after oral pouch tobacco
use, the relationship between extent of constituent extraction and biomarkers of exposure,
and finally, withdrawal symptoms from the oral tobacco products. Two sites will be used for
these studies: University of Minnesota and Oregon Research Institute (ORI).


Inclusion Criteria:



- smoking at least 10 cigarettes daily for the past year,

- in good physical health (no unstable medical condition;

- no contraindications for medicinal nicotine, as appropriate for the study, d) 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Smoking cessation

Outcome Time Frame:

12, 13, 26 and 52 week post smoking cessation

Safety Issue:

No

Principal Investigator

Dorothy Hatsukami, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute

Authority:

United States: Federal Government

Study ID:

1R01 CA135884-2

NCT ID:

NCT00710034

Start Date:

November 2009

Completion Date:

January 2012

Related Keywords:

  • Tobacco Use Disorder
  • Oral Tobacco Products
  • Smoking Cessation
  • Harm Reduction
  • Biomarkers of tobacco exposure
  • Tobacco Use Disorder

Name

Location

University of MinnesotaMinneapolis, Minnesota  55455
Oregon Research InstituteEugene, Oregon  97403