Examining lung inflammation differences in smokers and vapers

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

This study is testing how lung inflammation differs between people who smoke cigarettes, those who use e-cigarettes, and non-smokers by using a special scan and blood tests.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Pennsylvania (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT03721822 on ClinicalTrials.gov

What this trial studies

This research aims to measure lung inflammation levels among different groups using a radioactive tracer called [18F]NOS. Participants will undergo a PET/CT scan to visualize how the tracer accumulates in the lungs, allowing researchers to compare inflammation between e-cigarette users, cigarette smokers, and non-smokers. Blood samples will also be collected to assess inflammation markers and tracer concentration during the scan. The study is conducted under an FDA-approved Investigational New Drug Application.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-45 who are current smokers, e-cigarette users, or non-smokers.

Not a fit: Patients who do not fall within the specified age range or smoking/vaping criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the inflammatory effects of smoking and vaping, potentially guiding better treatment and prevention strategies.

How similar studies have performed: While studies on smoking and lung inflammation exist, the use of [18F]NOS for this specific comparison is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Jacob Dubroff, MD, PhD — University of Pennsylvania
• Study coordinator: Erin Schubert

Conditions Smoking, Cigarette; Smoking E-cigarette; Healthy Volunteer