NCT02415270

Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Tobacco Smoking Behavior

Interventions

Type	Name	Description
OTHER	Reduced Nicotine Cigarettes	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
OTHER	Reduced ROS/RNS	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
OTHER	Control	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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-04-14
• Last updated: 2018-07-27

Locations

1 site across 1 country: United States