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Switching to Low Oxidant Content Cigarettes in Adult Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102931
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : March 4, 2019
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 objective of this clinical study is to determine if smokers who switch from their usual high reactive oxygen and nitrous oxide species (ROS/NOS) products to a low ROS/NOS product exhibit increased or decreased levels of oxidative stress/damage, respectively.

Condition or disease Intervention/treatment Phase
Nicotine Oxidative Stress Other: Reduced ROS/RNS content products Other: Typical to high (ROS/NOS) products Not Applicable

Detailed Description:

Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between the ages of 21-65 who smoke at least 10 cigarettes a day for at least one year.

The aim of this study is to evaluate the effect of reduced oxidative/ nitrogen species (ROS/RNS) cigarettes compared to high ROS/RNS cigarettes.

Study participation lasts 8 weeks, with 5 study visits at the Hershey Medical Center. All eligible participants will be given Spectrum research cigarettes, provided free of charge, and will be asked to only smoke those cigarettes for the first four weeks of the study. Following that four-week period of time all participants will be given low ROS content cigarettes (American Spirit Dark Green or Pall Mall Red). Participants will be asked to smoke only these cigarettes for the final four weeks of the study, these cigarettes will also be provided to you free of charge.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Switching to Low Oxidant Content Cigarettes in Adult Smokers
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : March 6, 2018
Actual Study Completion Date : March 6, 2018

Arm Intervention/treatment
Experimental: Reduced ROS/RNS content products
Participants will be given and asked to smoke research cigarettes for the first 4 weeks. For the final 4 weeks of the study they will be given and asked to smoke low ROS content cigarettes.
Other: Reduced ROS/RNS content products
Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.

Other: Typical to high (ROS/NOS) products
Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.




Primary Outcome Measures :
  1. Biomarkers of oxidative stress [ Time Frame: 8 weeks ]
    The primary endpoint is to assess whether levels of oxidative stress/damage increase or decrease when a smoker switches from a high ROS/NOS cigarette product to a low ROS/NOS product. The biomarkers that will be used to assess oxidative stress include: 8-0HdG, glutathionylated proteins, and urinary F,-isoprostanes cysteine and GSH.


Secondary Outcome Measures :
  1. Antioxidant and nutrient levels in the blood [ Time Frame: 8 weeks ]
    Secondary endpoints include measurements of nicotine exposure (urine or plasma cotinine).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 per day or more for at least one year
  • Read and write in English
  • Menthol and nonmenthol smokers
  • Able to understand and provide consent to study procedures
  • Plan to live in the local area for the next 3 months
  • 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 3 months (ensuring stability of smoking)

Exclusion Criteria:

  • Currently pregnant or nursing
  • Unstable or significant medical conditions that affect oxidative stress, such as COPD, kidney failure, heart disease, stroke, cancer, tumors, lung or respiratory disease, diabetes, liver disease, autoimmune disorder, rheumatoid arthritis, infectious disease or fibromyalgia.
  • Use of non-cigarette nicotine delivery
  • History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
  • Current or recent history of substance or alcohol abuse
  • No more than seven alcoholic drinks a week, and/ or >two drinks a day
  • Use of a high dose antioxidant supplement prior to 1 month
  • Currently smoking cigarettes that will be used for the study (Pall Mall Red or American Spirit Dark Green)

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): NCT03102931


Locations
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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
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Principal Investigator: John Richie, Ph.D Milton S. Hershey Medical Center
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Responsible Party: John P. Richie, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03102931    
Other Study ID Numbers: STUDY00006759
5P50DA036107-02 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
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.

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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