Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users

Who is this study for? Adult patients that Smoke Cigarettes
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this research is to measure the extent of lung inflammation between different groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Participants will be 18-45 years of age

• Subject must meet one of the following criteria:

• NIC vapers: current e-cigarette use of nicotine at least 5 days per week for the past year, no current combustible cigarette use, cannabis vaping, or cannabis smoking during the 30 days prior to study enrollment

• CAN vapers: current e-cigarette use of cannabis at least 5 days per week for the past year, no current combustible cigarette use, cannabis smoking, or nicotine vaping during the 30 days prior to study enrollment

• Cigarette smokers: current cigarette smoking of at least 5 cigarettes per day, 4 days per week for the past year with no e-cigarette use (cannabis or nicotine) or cannabis smoking during the 30 days prior to study enrollment

• Dual combustible and e-cigarette users: current e-cigarette use of cannabis and/or nicotine at least 5 days per week for the past year with cigarette or cannabis smoking during the 30 day prior to study enrollment

• Non-Smokers: reported non-smoking history or < 100 lifetime cigarettes, < 100 e-cigarette use episodes, and < 100 lifetime cannabis use episodes

• Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Locations
United States
Pennsylvania
University of Pennsylvania
Recruiting
Philadelphia
Contact Information
Primary
Erin Schubert
erinschu@pennmedicine.upenn.edu
215-573-6569
Time Frame
Start Date: October 23, 2018
Estimated Completion Date: October 23, 2023
Participants
Target number of participants: 100
Treatments
Experimental: Traditional Cigarette Smokers
Reported current cigarette smoking of at least 5 cigarettes per day, 5 days per week for the past 1 year with no history of e-cigarette use (cannabis or nicotine) or cannabis smoking during the 30 days prior to study enrollment
Experimental: Non-Smokers
Reported non-smoking history or < 100 lifetime cigarettes, < 100 e-cigarette use episodes and < 100 lifetime cannabis use episodes
Experimental: Nicotine Vapers
Reported current e-cigarette use of nicotine at least 5 days per week for the past year with no current combustible cigarette use, cannabis vaping or cannabis smoking during the 30 days prior to study enrollment
Experimental: Cannabis Vapers
Reported current e-cigarette use of cannabis at least 5 days per week for the past year, no current combustible cigarette use, cannabis smoking or nicotine vaping during the 30 days prior to study enrollment
Experimental: Dual Smokers/Vapers
Reported current e-cigarette use of cannabis and/or nicotine at least 5 days per week for the past year with cigarette or cannabis smoking during the 30 days prior to study enrollment
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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