Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02415270
• Collaborator: Food and Drug Administration (FDA) (U.S. Fed), National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 37
• Location: 1
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Smoking Behavior	Other: Reduced Nicotine Cigarettes; Other: Reduced ROS/RNS; Other: Control	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reduced Nicotine Cigarettes Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.	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 Names: Cigarette contains .28mg (.29mg/menthol) of nicotine
Experimental: Reduced ROS/RNS Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.	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 Names: Cigarette to be determined by lab experiment
Placebo Comparator: Control Group Participants will be assigned to continue smoking their usual brand of cigarettes.	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• Food and Drug Administration (FDA)
• National Institutes of Health (NIH)
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: John Richie, Ph.D, Milton S. Hershey Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John P. Richie, Principal Investigator, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02415270
• Other Study ID Numbers: STUDY00001996; 5P50DA036107-02
• First Posted: Apr 14, 2015
• Last Update Posted: Jul 27, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Menthol; Nicotine

Study Results

No Results Posted as of Jul 27, 2018