Switching to Low Oxidant Content Cigarettes in Adult Smokers

NCT ID: NCT03102931

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2018-03-06

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.

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.

Conditions

Nicotine; Oxidative Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reduced ROS/RNS content products

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John P. Richie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Richie, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

5P50DA036107-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006759

Identifier Type: -

Identifier Source: org_study_id