Smoking, CigarettePhase 1NCT03721822
Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation
A Phase 1 study testing [18F]NOS in people with Smoking, Cigarette and Smoking E-cigarette, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette, Smoking E-cigarette, Healthy Volunteer
- What is being tested?
- [18F]NOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 23 Oct 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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) 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.
Who cannot join
- 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.
- Current untreated and unstable diagnosis of substance use disorder, except nicotine use disorder or cannabis use disorder
- Positive urine drug screen for opiates, methamphetamine or cocaine at screening
- Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported
- Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report
- History of lung trauma
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- 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)
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569, erinschu@pennmedicine.upenn.edu
Jacob Dubroff, MD, PhD
About this study
Official title: Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users
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.
Read the detailed description
This study will see how the tracer is taken up in the lungs using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). [18F]NOS is an experimental radioactive molecule used in PET imaging to measure inflammation in various organs in the body. Investigators are interested in studying whether there are differences in lung inflammation between E-cigarette users (vapers) cigarette smokers and non-smokers. [18F]NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use of [18F]NOS in this study is allowed under an Investigational New Drug Application approved by the FDA.
Investigators are also going to be studying how the information from the PET/CT scan compares to other markers of inflammation in the blood. During the PET scan, Investigators will image Brain and Lungs in order to see if there is a difference between inflammation seen in the brain and the lungs and if these differences change depending on whether a subject is a smoker, e-cigarette user or non-smoker.
Consented participant in this study will undergo one (1) experimental [18F]NOS PET/CT scan. During the scan, PET/CT images will be taken of participant chest/torso in order to capture their lungs and a short image will be taken of their brain. Blood samples will be taken at various time points to test for markers of inflammation and to measure the concentration of the tracer in participants blood during the scan and participants will undergo some specific psychological questionnaires and tasks.
- Conditions
- Smoking, Cigarette, Smoking E-cigarette, Healthy Volunteer
- Being tested
- [18F]NOS
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]NOSDrug
Also called [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine
[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Cigarette Smokers | Experimental | 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 Receives: Drug: [18F]NOS |
| Non-Smokers | Experimental | Reported non-smoking history or < 100 lifetime cigarettes, < 100 e-cigarette use episodes and < 100 lifetime cannabis use episodes Receives: Drug: [18F]NOS |
| Nicotine Vapers | Experimental | 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 Receives: Drug: [18F]NOS |
| Cannabis Vapers | Experimental | 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 Receives: Drug: [18F]NOS |
| Dual Smokers/Vapers | Experimental | 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 Receives: Drug: [18F]NOS |
| Poly-use nicotine and cannabis group | Experimental | 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. Receives: Drug: [18F]NOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung inflammation using [18F]NOS PET/CT
lung inflammation using [18F]NOS PET/CT and compare uptake in ENDS users to traditional cigarette smokers and non-smokers.
Measured: 3 years
Secondary outcomes (2)
relationship between [18F]NOS uptake and peripheral inflammatory biomarkers
relationship between [18F]NOS uptake measures and established peripheral inflammatory biomarkers (e.g. C-reactive protein and Il-6).
Measured: 3 years
differences in brain inflammation between three cohort using [18F]NOS PET/CT]
Using [18F]NOS PET/CT to explore relative differences in brain inflammation between ENDS users, traditional cigarette smokers and non-smokers.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start23 Oct 2018
- Primary completion23 Oct 2027 (estimated)
- Study completion23 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Dubroff, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721822
- Sponsor's protocol ID
- 831205
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2018
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No