Switching to Low Oxidant Content Cigarettes in Adult Smokers

Oxidative Stress Clinical Trial

Official title:

Switching to Low Oxidant Content Cigarettes in Adult Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102931
• Other study ID #: STUDY00006759
• Secondary ID: 5P50DA036107-02
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: March 6, 2018

Study information

• Verified date: February 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 6, 2018
• Est. primary completion date: March 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nicotine
• Oxidative Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Penn State Hershey	Hershey	Pennsylvania

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of oxidative stress	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.	8 weeks
Secondary	Antioxidant and nutrient levels in the blood	Secondary endpoints include measurements of nicotine exposure (urine or plasma cotinine).	8 weeks