Palatability of Experimental Cigarettes
18 Years
64 Years
Both
Smoking
Trial Information
Palatability of Experimental Cigarettes
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Comparison of Urine Cotinine Levels and Total Nicotine Equivalent (TNE)
Outcome Description:
Two urine cotinine levels are taken, one at baseline and one at week 1, to assess cotinine levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucouronide conjugates.
Outcome Time Frame:
Baseline (Day 1) Compared to Week 1
Safety Issue:
No
Principal Investigator
Dorothy Hatsukami, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tobacco Use Research Program, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2011NTLS004
NCT ID:
NCT01568905
Start Date:
February 2011
Completion Date:
March 2013
Related Keywords:
- Smoking
- smoker
- smoking
- nicotine levels
- tobacco
- nicotine
- Smoking
Name | Location |
|---|---|
| University of Minnesota | Minneapolis, Minnesota 55455 |
