Recruiting
Phase 1

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT03721822

Conditions

Smoking, Cigarette

Smoking E-cigarette

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

[18F]NOS

Study Details

Brief 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.

Conditions

Smoking, Cigarette

Smoking E-cigarette

Healthy Volunteer

Study ID

NCT03721822

Start date

Oct 23, 2018

Status verified date

Sep, 2025

Completion date

Oct 23, 2026

Anticipated

Primary completion date

Oct 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Participants will be 18-45 years of age
2. 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) 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
3. 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.

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening and on scan day.
2. Current untreated and unstable diagnosis of substance use disorder, except nicotine use disorder or cannabis use disorder
3. Positive urine drug screen for opiates, methamphetamine or cocaine at screening
4. Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported
5. Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report
6. History of lung trauma
7. Active (or within the previous 4 weeks of screening) lung infection or lung disease that impact uptake of \[18F\]NOS (e.g. tuberculosis, cystic fibrosis)
8. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
9. Any current or past medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

[18F]NOS

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

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Jacob Dubroff, MD, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-03.