Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers
Condition: Tobacco Smoking Behavior
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Reduced Nicotine Cigarettes; Reduced ROS/RNS; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups; Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups; Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Other intervention name(s): Cigarette contains .28mg (.29mg/menthol) of nicotine; Cigarette to be determined by lab experiment
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research