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Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

Primary Purpose

Smoking, Cigarette, Smoking E-cigarette, Healthy Volunteer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]NOS
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Smoking, Cigarette

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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) or cannabis smoking 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. Reported regular use of nicotine or cannabis products (except edibles) other than ENDS, cigarettes, or cannabis bowls, pipes, or blunts (e.g., smokeless tobacco, nicotine replacement therapy, wax, shatter, tinctures)
  5. Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported
  6. Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report
  7. History of lung trauma
  8. 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)
  9. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  10. 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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Traditional Cigarette Smokers

Non-Smokers

Nicotine Vapers

Cannabis Vapers

Dual Smokers/Vapers

Arm Description

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

Reported non-smoking history or < 100 lifetime cigarettes, < 100 e-cigarette use episodes and < 100 lifetime cannabis use episodes

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
October 25, 2018
Last Updated
January 19, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03721822
Brief Title
Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation
Official Title
Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
October 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Cigarette, Smoking E-cigarette, Healthy Volunteer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Cigarette Smokers
Arm Type
Experimental
Arm Description
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
Arm Title
Non-Smokers
Arm Type
Experimental
Arm Description
Reported non-smoking history or < 100 lifetime cigarettes, < 100 e-cigarette use episodes and < 100 lifetime cannabis use episodes
Arm Title
Nicotine Vapers
Arm Type
Experimental
Arm Description
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
Arm Title
Cannabis Vapers
Arm Type
Experimental
Arm Description
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
Arm Title
Dual Smokers/Vapers
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
[18F]NOS
Other Intervention Name(s)
[18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine
Intervention Description
[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 Information:
Title
lung inflammation using [18F]NOS PET/CT
Description
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 Outcome Measure Information:
Title
relationship between [18F]NOS uptake and peripheral inflammatory biomarkers
Description
relationship between [18F]NOS uptake measures and established peripheral inflammatory biomarkers (e.g. C-reactive protein and Il-6).
Time Frame
3 years
Title
differences in brain inflammation between three cohort using [18F]NOS PET/CT]
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Reported regular use of nicotine or cannabis products (except edibles) other than ENDS, cigarettes, or cannabis bowls, pipes, or blunts (e.g., smokeless tobacco, nicotine replacement therapy, wax, shatter, tinctures) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Schubert
Phone
215-573-6569
Email
erinschu@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Dubroff, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Schubert
Phone
215-573-6569
Email
erinschu@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Jacob Dubroff, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

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