Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT03721822
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer
  • Smoking E-cigarette
  • Smoking, Cigarette

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • [18F]NOS — DRUG
    \[18F\]NOS is an investigational radiotracer which each subject will have one \[18F\]NOS positron emission tomography/computed tomography (PET/CT) scan performed.

Study Details

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.

Key Dates

Start date
Oct 23, 2018
Status verified
Sep 2025
Primary completion
Oct 23, 2026
Completion
Oct 23, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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) 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
  • Experimental: Poly-use nicotine and cannabis group
    Poly-use nicotine and cannabis group: current e-cigarette use of nicotine and/or cigarette use (5 cigarettes per day) and/or use of cannabis, at least 4 days per week during the 30 days prior to study enrollment.

Primary Outcome Measure

lung inflammation using [18F]NOS PET/CT [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Erin Schubert
[email protected]
215-573-6569
Jacob Dubroff, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA

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