Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction
NCT ID: NCT00264342
Last Updated: 2013-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
2005-07-31
2010-07-31
Brief Summary
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Detailed Description
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We hypothesize that smokers of cigarettes with progressively reduced nicotine content will experience a reduction in nicotine intake without compensatory oversmoking. This will serve to "wean" them from nicotine and result in a decreased level of nicotine dependence. Once this has occurred, subjects will then be able to maintain their reduced level of nicotine intake for the 6 months that they continue smoking the lowest level RNC cigarette. When they are again free to choose any smoking behavior (follow-up phase), as a result of the period of lowered dependence they will smoke fewer cigarettes and/or have a greater interest in quitting compared to the control group, whose level of nicotine dependence is hypothesized to be sustained throughout.
Primary Hypotheses:
1. Nicotine intake will be lower for the RNC group than for the control group.
2. Exposure to tobacco smoke gas phase constituents will be similar for the RNC and control group.
3. Exposure to tobacco smoke tar constituents will be similar for the RNC and control group.
4. Cardiovascular biomarkers of inflammation, platelet activation, endothelial dysfunction, and HDL cholesterol will be lower for the RNC group than for the control group.
5. Cigarette consumption, as measured by cigarettes-per-day (CPD), will be lower for the RNC group than for the control group.
Secondary hypotheses:
1. Over the course of tapering and maintenance and at follow-up, interest in quitting will be higher in the RNC group compared to the control group.
2. At follow-up, measures of cigarette consumption, nicotine intake, and exposure to tobacco smoke combustion constituents will be lower for the RNC group compared to the control group.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Current moderate-to-heavy smoker as determined by:
1. smoking more than 10 cigarettes per day regularly for the past year (by history); and
2. expired carbon monoxide (CO) at screening visit of 25 ppm or more and/or plasma cotinine level of 100 ng/ml or more.
* Age 18-70 years
* Any racial/ethnic background
Exclusion Criteria
* Significant medical conditions (such as anemia, heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants). Smokers with uncomplicated controlled hypertension may be enrolled.
* Pregnancy or lactation (by history)
* Current use of smokeless tobacco, pipes or cigars
* Alcohol abuse or illicit drug use (by history)
* Concurrent participation in another clinical trial or prior participation in our pilot studies using the same RNC cigarettes as in these studies
18 Years
70 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Neal L Benowitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Benowitz NL, Jacob P 3rd, Bernert JT, Wilson M, Wang L, Allen F, Dempsey D. Carcinogen exposure during short-term switching from regular to "light" cigarettes. Cancer Epidemiol Biomarkers Prev. 2005 Jun;14(6):1376-83. doi: 10.1158/1055-9965.EPI-04-0667.
Gray N, Henningfield JE, Benowitz NL, Connolly GN, Dresler C, Fagerstrom K, Jarvis MJ, Boyle P. Toward a comprehensive long term nicotine policy. Tob Control. 2005 Jun;14(3):161-5. doi: 10.1136/tc.2004.010272.
Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.
Arcavi L, Benowitz NL. Cigarette smoking and infection. Arch Intern Med. 2004 Nov 8;164(20):2206-16. doi: 10.1001/archinte.164.20.2206.
Swan GE, Benowitz NL, Jacob P 3rd, Lessov CN, Tyndale RF, Wilhelmsen K, Krasnow RE, McElroy MR, Moore SE, Wambach M. Pharmacogenetics of nicotine metabolism in twins: methods and procedures. Twin Res. 2004 Oct;7(5):435-48. doi: 10.1375/1369052042335269.
Benowitz NL, Gan Q, Goniewicz ML, Lu W, Xu J, Li X, Jacob P 3rd, Glantz S. Different profiles of carcinogen exposure in Chinese compared with US cigarette smokers. Tob Control. 2015 Dec;24(e4):e258-63. doi: 10.1136/tobaccocontrol-2014-051945. Epub 2014 Dec 22.
Related Links
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UCSF Nicotine and Tobacco Research
Other Identifiers
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