Tobacco Smoking Behavior Clinical Trial
Official title:
Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
The overall objectives of this clinical study are to determine in smokers the short term effects of switching to tobacco products that deliver low levels of nicotine or reactive oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke exposure and oxidative stress.
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65
who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol,
Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L&M Menthol, Pyramid Red,
Newport Red, Newport Menthol.
If you smoke one of these brand styles on a regular basis you may be eligible to participate
in a compensated short term study on health and smoking behavior at Penn State Hershey
Medical Center.
Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are
asked to use their usual brand for one week and then switch to 1 of 3 brands for the
remaining two weeks. The three brands participants are randomly assigned to after the first
week of participation are either Group 1. reduced nicotine content cigarette (Spectrum
Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to
Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only
these until the end of the study. All cigarettes following visit 1 will be provided free of
charge.
Study overview:
Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview
Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette
butts on 1 day
Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete
a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2
days Collect cigarette butts on 1 day
Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute
interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect
cigarette butts on 1 day
Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute
interview Sign compensation form
For information on additional tobacco studies being conducted at Penn State Hershey, please
call 1-844-207-6392
*This research is being conducted under the investigator John Richie at Penn State Hershey;
500 University Drive Hershey, PA
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