View Clinical Trial (Medical Research Study)
Palatability of Experimental Cigarettes
| City: |
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Minneapolis |
| State: |
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Minnesota |
| Zip Code: |
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55414 |
| Conditions: |
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Smoking |
| Purpose: |
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Smoking remains a leading cause of preventable disease and premature death worldwide.
Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half
of all daily smokers will die prematurely from tobacco-related illness. Reducing the
nicotine in cigarettes to the point that they are rendered non-addictive can potentially be
an effective public policy measure that can significantly reduce tobacco-related mortality
and morbidity by decreasing the initiation of smoking and promoting cessation. The Family
Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco
product standards including placing limits on the allowable nicotine content of cigarettes.
Currently, no reduced nicotine cigarettes are available that will allow studying the
feasibility of this policy measure. The National Institute on Drug Abuse has contracted with
Research Triangle Institute to assist in the development of cigarettes with varying nicotine
content that can be made available to researchers. They have established a contract that
will result in the manufacture of 9 million cigarettes to be distributed to the research
community. Prior to full production, the palatability and nicotine intake of these
cigarettes in smokers must be determined.
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| Study Summary: |
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Phase 3: This descriptive study will use a between subjects, double blind design. This study
will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research
assistants will be blind to the cigarette type.
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| Criteria: |
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Inclusion Criteria:
- 18-64 years old
- Regular smokers (10+ cigarettes per day and has done so for the last year)
- Inhaling when smoking
- Carbon monoxide (CO) > 8 ppm
Exclusion Criteria:
- In the past year, suffered from any cardiovascular disease such as: heart disease,
heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis
or chronic obstructive pulmonary disease (COPD), any type of cancer
- Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia,
or a major depressive episode
- Taken any of the following drugs more than twice per week during the past month:
antidepressants, anti-anxiety medications.
- Consumed more than 15 alcoholic drinks per week for the past month
- Pregnant, trying to become pregnant, or lactating (assessed by self-report)
- In the past 3 months, used nicotine replacement products (like the patch, gum, or
inhaler), or the medications bupropion varenicline
- Currently trying or planning to reduce or quit tobacco use in the next 30 days
- Used other forms of tobacco 10 or more days in the past 30 days
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| NCT ID: |
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NCT01568905 |
| Primary Contact: |
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Principal Investigator
Dorothy Hatsukami, Ph.D.
Tobacco Use Research Program, University of Minnesota
Dorothy Hatsukami, Ph.D.
Phone: 612-626-2121
Email: hatsu001@umn.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Minneapolis, Minnesota 55414
United States
Dorothy Hatsukami, Ph.D.
Phone: 612-626-2121
Email: hatsu001@umn.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
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