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Completed

NCT Number: NCT03102931

Switching to Low Oxidant Content Cigarettes in Adult Smokers

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.

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Key information

Conditions

Nicotine Oxidative Stress

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Reduced ROS/RNS content products

Other

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.

Typical to high (ROS/NOS) products

Other

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 outcomes

  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 outcomes

  1. Antioxidant and nutrient levels in the blood

    Time frame: 8 weeks

    Secondary endpoints include measurements of nicotine exposure (urine or plasma cotinine).

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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