Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction
Tobacco Use Disorder
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Safety of Nicotine Reduction Strategy|
|Study Start Date:||July 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
This is a 2-year, randomized, two-arm study involving a 6-month period of progressive reduction in the nicotine content of cigarettes. During the first year (tapering/maintenance phases), subjects will smoke progressively reduced nicotine content (RNC) cigarettes over a period of six months, and then remain on the lowest nicotine content cigarette for an additional six months. Comparisons will be made with a control group in which subjects will smoke their usual normal nicotine yield cigarettes. There will be a one year follow-up phase during which subjects will be monitored and will be free to resume smoking a commercial cigarette of their choice, or to quit.
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.
- Nicotine intake will be lower for the RNC group than for the control group.
- Exposure to tobacco smoke gas phase constituents will be similar for the RNC and control group.
- Exposure to tobacco smoke tar constituents will be similar for the RNC and control group.
- Cardiovascular biomarkers of inflammation, platelet activation, endothelial dysfunction, and HDL cholesterol will be lower for the RNC group than for the control group.
- Cigarette consumption, as measured by cigarettes-per-day (CPD), will be lower for the RNC group than for the control group.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264342
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Neal L Benowitz, MD||University of California, San Francisco|