Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers
NCT ID: NCT02415270
Last Updated: 2018-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2016-01-31
2017-01-01
Brief Summary
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Detailed Description
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If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.
Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.
Study overview:
Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form
For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392
\*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Reduced Nicotine Cigarettes
Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.
Reduced Nicotine Cigarettes
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Reduced ROS/RNS
Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.
Reduced ROS/RNS
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Control Group
Participants will be assigned to continue smoking their usual brand of cigarettes.
Control
Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Interventions
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Reduced Nicotine Cigarettes
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Reduced ROS/RNS
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Control
Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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Food and Drug Administration (FDA)
FED
National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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John P. Richie
Principal Investigator
Principal Investigators
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John Richie, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Hershey
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY00001996
Identifier Type: -
Identifier Source: org_study_id
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