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New treatment option for Smoking, Cigarette
Official title Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation
ClinicalTrials.gov ID: NCT03721822
What this study is testing
What is [18F]NOS?
[18F]NOS is an investigational medicine, being studied as a potential treatment for smoking, cigarette.
Also referred to as [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join 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...
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this...
You likely can't join 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...
- 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
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.