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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Minnesota |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218283 |
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While there are many treatment programs that focus on stopping tobacco use, there are no interventions that specifically focus on reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing tobacco use in ST users.
Condition | Intervention | Phase |
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Tobacco Use Disorder |
Drug: Nicotine Lozenge Behavioral: Behavioral Counseling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Smokeless Tobacco Users |
Enrollment: | 100 |
Study Start Date: | January 2005 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 - Nicotine Lozenge: Experimental
Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date.
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Drug: Nicotine Lozenge
Oral Nicotine replacement product
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2 Behavioral counseling: Placebo Comparator
Use of behavioral counseling alone to help reduce tobacco use prior to quit date.
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Behavioral: Behavioral Counseling
Use of behavioral counseling to reduce tobacco use.
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Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. The need exists for a program specifically aimed towards reducing, rather than quitting, tobacco use. The purpose of this study is to evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the motivation to either quit or sustain lower levels of ST use.
This 8-week study will enroll frequent users of ST. Participants will be randomly assigned to receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone. All participants will be asked to alternate use of their usual ST brand with nicotine lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the following 4 weeks. Participants will be required to maintain a daily tobacco use diary. Study visits will occur once a week. Tobacco levels will be monitored with urine tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations will occur 12 and 26 weeks following the end of treatment.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Dorothy Hatsukami, PhD | University of Minnesota |
Responsible Party: | University of Minnesota ( Dorothy Hatsukami ) |
Study ID Numbers: | NIDA-14404-3, R01-14404-3, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00218283 |
Health Authority: | United States: Food and Drug Administration |
Nicotine Dependence Tobacco Dependence |
Nicotine polacrilex Lobeline Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |