Clinical trial NCT03102931: Switching to Low Oxidant Content Cigarettes in Adult Smokers
Official title: Switching to Low Oxidant Content Cigarettes in Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine
Oxidative Stress
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Biomarkers of oxidative stress
timeFrame: 8 weeks
Secondary outcomes:
measure: Antioxidant and nutrient levels in the blood
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: John Richie, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: