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
18 Years
70 Years
Both
Tobacco Use Disorder
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 Minnesota | Minneapolis, Minnesota 55455 |
| Oregon Research Institute | Eugene, Oregon 97403 |
