Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

NCT03721822 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 831205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  3 years

Secondary Outcomes (2)

• relationship between [18F]NOS uptake and peripheral inflammatory biomarkers

  3 years

• differences in brain inflammation between three cohort using [18F]NOS PET/CT]

  3 years

Study Arms (6)

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

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

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

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

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

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.

Drug: [18F]NOS

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.

Also known as: [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine

Cannabis Vapers; Dual Smokers/Vapers; Nicotine Vapers; Non-Smokers; Poly-use nicotine and cannabis group; Traditional Cigarette Smokers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Fluorine-18

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Jacob Dubroff, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Schubert

CONTACT

215-573-6569; erinschu@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: October 23, 2018
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)