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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Nicotine
• Intervention / Treatment: Other: Reduced ROS/RNS content products; Other: Typical to high (ROS/NOS) products

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antioxidant and nutrient levels in the blood	Secondary endpoints include measurements of nicotine exposure (urine or plasma cotinine).	8 weeks

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH); Food and Drug Administration (FDA)
• Investigators: Principal Investigator: John Richie, Ph.D, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): March 6, 2018
• Study Completion (Actual): March 6, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00006759; 5P50DA036107-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time we have no plan for sharing, however if need should arise, then sharing may be a possibility.

Drug and device information, study documents

• 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