Tobacco Smoking Behavior Clinical Trial
Official title:
Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
Verified date | July 2018 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall objectives of this clinical study are to determine in smokers the short term effects of switching to tobacco products that deliver low levels of nicotine or reactive oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke exposure and oxidative stress.
Status | Completed |
Enrollment | 37 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 21-65 - Smoke 10 cigarettes/day or more for at least one year - Read and write in English - Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes - Able to understand and provide consent to study procedures - Plan to live in the local area for the next month - 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 month Exclusion Criteria: - Currently pregnant or nursing - Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data - Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana) - Currently reducing or planning to reduce cigarette consumption in the next month - Use of smoking cessation medicine in the past 3 months - History of difficulties providing blood samples: fainting, poor veins, anxiety, etc. - Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate) - Significant medical condition, i.e. stroke, MI, cancer, in the last month - Currently using illegal drugs |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Hershey | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Topography | measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument. | 8 days | |
Secondary | Biomarkers of oxidative stress | biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG). | 4 times over the 22 day study period |
Status | Clinical Trial | Phase | |
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