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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00710034 |
Purpose
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in smoking; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period. For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms and negative affect from cigarette abstinence, but smokers who are assigned to the oral tobacco product will be more likely to report liking the effects from their assigned product compared to those smokers assigned to medicinal nicotine; 2) greater physiological effects (e.g., vitals) will be observed for the oral tobacco product compared to medicinal nicotine; 3) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine; 4) although the abstinence rates will be higher for oral tobacco products, and initial product costs will be lower, relative to the nicotine gum intervention, the likelihood of longer duration of oral tobacco use will increase the oral tobacco cost over time for the user; and 5) switching to low-nitrosamine oral tobacco will reduce life-years lost compared to continuing smoking and will be a cost-effective (in terms of life-years saved) cessation strategy compared to medicinal nicotine.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Use Disorder |
Other: Oral tobacco Drug: Nicotine replacement |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Nicotine replacement therapy
|
Drug: Nicotine replacement
4 mg Nicotine gum
|
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2: Experimental
Oral tobacco
|
Other: Oral tobacco
To be determined by Study 1
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
Contacts and Locations| Contact: Joni A Jensen, MPH | 612-627-4903 | jense010@umn.edu |
| Contact: Amanda Anderson, BA | 612-627-1821 | ander411@umn.edu |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55414 | |
| United States, Oregon | |
| Oregon Research Institute | |
| Eugene, Oregon, United States, 97403 | |
| Principal Investigator: | Dorothy Hatsukami, Ph.D. | University of Minnesota |
More Information
| Responsible Party: | University of Minnesota ( Dorothy Hatsukami ) |
| Study ID Numbers: | Study 2, 1R01CA135884 |
| Study First Received: | July 2, 2008 |
| Last Updated: | January 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00710034 History of Changes |
| Health Authority: | United States: Federal Government |
|
Oral Tobacco Products Smoking Cessation Harm Reduction Biomarkers of tobacco exposure |
|
Nicotine polacrilex Smoking Neurotransmitter Agents Nicotine Mental Disorders Nicotinic Agonists |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin Central Nervous System Stimulants Peripheral Nervous System Agents Cholinergic Agents |
|
Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Tobacco Use Disorder Nicotinic Agonists Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Mental Disorders Nicotine Autonomic Agents Therapeutic Uses Substance-Related Disorders Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |
