Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

Not Applicable

Completed

• Conditions: Tobacco Smoking Behavior
• Interventions: Other: Reduced ROS/RNS; Other: Control; Other: Reduced Nicotine Cigarettes

• Registration Number: NCT02415270
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-14
• Study Start: 2016-01
• Primary Completion: 2017-01
• Study Completion: 2017-01-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Age 21-65
• Smoke 10 cigarettes/day or more for at least one year
• Read and write in English
• Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes
• Able to understand and provide consent to study procedures
• Plan to live in the local area for the next month
• Women not pregnant or nursing and taking steps to avoid pregnancy
• No quit attempt in the last one months and not planning to quit in the next month

Exclusion Criteria

• Currently pregnant or nursing
• Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data
• Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana)
• Currently reducing or planning to reduce cigarette consumption in the next month
• Use of smoking cessation medicine in the past 3 months
• History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
• Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate)
• Significant medical condition, i.e. stroke, MI, cancer, in the last month
• Currently using illegal drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced ROS/RNS	Reduced ROS/RNS	Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.
Control Group	Control	Participants will be assigned to continue smoking their usual brand of cigarettes.
Reduced Nicotine Cigarettes	Reduced Nicotine Cigarettes	Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.

Primary Outcome Measures

Name	Time	Method
Smoking Topography	8 days	measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.

Secondary Outcome Measures

Name	Time	Method
Biomarkers of oxidative stress	4 times over the 22 day study period	biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG).

Trial Locations

Locations (1)

Penn State Hershey; 🇺🇸 Hershey, Pennsylvania, United States