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Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

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ClinicalTrials.gov Identifier: NCT02415270
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John P. Richie, 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.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Behavior Other: Reduced Nicotine Cigarettes Other: Reduced ROS/RNS Other: Control Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Smoking Topography [ Time Frame: 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 [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415270


Locations
United States, Pennsylvania
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

Responsible Party: John P. Richie, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02415270     History of Changes
Other Study ID Numbers: STUDY00001996
5P50DA036107-02 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At this time we have no plan for sharing, however if need should arise, then sharing may be a possibility.

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:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action