Health TrialsbyHealthPanel

Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

ConditionsSmoking, CigaretteSmoking E-cigaretteHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Pennsylvania

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Participants will be 18-45 years of age

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • [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.

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Traditional Cigarette SmokersExperimental treatment 1 intervention
Group B: Non-SmokersExperimental treatment 1 intervention
Group C: Nicotine VapersExperimental treatment 1 intervention
Group D: Cannabis VapersExperimental treatment 1 intervention
Group E: Dual Smokers/VapersExperimental treatment 1 intervention
Group F: Poly-use nicotine and cannabis groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years

Secondary outcomes

1

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).

Time frame
3 years
2

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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