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[18F]NOS Imaging for Lung Inflammation
Phase 1
Recruiting
Led By Jacob Dubroff, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants will be 18-45 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will compare the extent of lung inflammation between smokers, ex-smokers, and never-smokers using a radioactive tracer.
Who is the study for?
This trial is for people aged 18-45 who are non-smokers, regular e-cigarette users (nicotine or cannabis), cigarette smokers, or dual users of cigarettes and e-cigarettes. Participants must not have lung diseases like tuberculosis, be on steroids/anti-inflammatory drugs, have untreated major depression/psychosis, or a history of lung trauma. Pregnant/breastfeeding women and those with certain drug use are excluded.Check my eligibility
What is being tested?
[18F]NOS, a radioactive tracer used in imaging to measure lung inflammation caused by smoking/vaping habits among different groups. The study involves injecting this substance into the body to track inflammation levels using special imaging techniques.See study design
What are the potential side effects?
Potential side effects may include reactions related to the injection site such as pain or swelling, allergic reactions to the tracer itself which could range from mild itching to more serious responses requiring medical attention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Select...
I smoke at least 5 cigarettes daily and haven't used e-cigarettes or smoked cannabis in the last 30 days.
Select...
I have smoked less than 100 cigarettes, used e-cigarettes, or cannabis in my life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
lung inflammation using [18F]NOS PET/CT
Secondary outcome measures
differences in brain inflammation between three cohort using [18F]NOS PET/CT]
relationship between [18F]NOS uptake and peripheral inflammatory biomarkers
Trial Design
5Treatment groups
Experimental Treatment
Group I: Traditional Cigarette SmokersExperimental Treatment1 Intervention
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
Group II: Non-SmokersExperimental Treatment1 Intervention
Reported non-smoking history or < 100 lifetime cigarettes, < 100 e-cigarette use episodes and < 100 lifetime cannabis use episodes
Group III: Nicotine VapersExperimental Treatment1 Intervention
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
Group IV: Dual Smokers/VapersExperimental Treatment1 Intervention
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
Group V: Cannabis VapersExperimental Treatment1 Intervention
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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,899 Total Patients Enrolled
Jacob Dubroff, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
4 Previous Clinical Trials
239 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently not receiving treatment for a substance use disorder, except for nicotine or cannabis use disorder.I haven't had a lung infection or disease affecting [18F]NOS uptake in the last 4 weeks.I am between 18 and 45 years old.I smoke at least 5 cigarettes daily and haven't used e-cigarettes in the last 30 days.I've been using e-cigarettes for cannabis almost daily for the past year and haven't smoked cigarettes, cannabis, or used nicotine vapes in the last month.You have tested positive for drugs like opiates, methamphetamine, or cocaine in your urine.I've used e-cigarettes and smoked cigarettes or cannabis almost daily for the last year.I have had a lung injury in the past.I use inhaled or oral corticosteroids or anti-inflammatory medications.I've been using nicotine e-cigarettes regularly for the past year and haven't smoked cigarettes or cannabis in the last 30 days.I smoke at least 5 cigarettes daily and haven't used e-cigarettes or smoked cannabis in the last 30 days.I have smoked less than 100 cigarettes, used e-cigarettes, or cannabis in my life.I regularly use nicotine or cannabis products that are not smoked.I am either a smoker, vaper, both, or a non-smoker.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional Cigarette Smokers
- Group 2: Non-Smokers
- Group 3: Nicotine Vapers
- Group 4: Cannabis Vapers
- Group 5: Dual Smokers/Vapers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participant enrollment in this trial?
"Indeed, the data available on clinicaltrials.gov reveals that this investigation is actively searching for participants. It was posted online in October 2018 and has been revised as recently as July 2022. The study requires 100 volunteers from around 1 centre."
Answered by AI
Is this medical research actively recruiting participants?
"This clinical trial is actively searching for patients as indicated by the data hosted on clinicaltrials.gov, with its initial posting occurring on October 23rd 2018 and a recent update being made to it in July 5th 2022."
Answered by AI
Does this research permit geriatric participants?
"This trial has a narrow age bracket, with only those between 18 and 45 being eligible. For patients younger than that or older than 65, there are 104 and 811 studies respectively to explore."
Answered by AI
Has the [18F]NOS compound been approved by the Food and Drug Administration?
"Considering the preliminary nature of this trial, our assessment at Power is that [18F]NOS's safety merits a score of 1. This Phase 1 study has only limited data to suggest its efficacy and safety profile."
Answered by AI
Is it possible to participate in this research experiment?
"This medical trial is recruiting 100 users of combustibles and/or electronic cigarettes, aged 18 to 45. The primary criteria are: dual combustible and e-cigarette smokers who have used nicotine or cannabis at least five times per week for the past year; vapers using either nicotine or cannabis exclusively in the same timeframe; cigarette smokers smoking a minimum of 5 sticks 4 days weekly without utilizing other forms of tobacco products concurrently; non-smokers with <100 lifetime instances of dabbling in any form of smoking product. Moreover, volunteers must be aware that this is an investigational study, giving their written consent according to institutional and governmental regulations before"
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Im financially suffering at the moment and i would like to see what information this study could offer.
PatientReceived 2+ prior treatments
I'm interested in the difference between regular cigarette smokers, vapers, vapers who only smoke cannabis & healthy volunteers.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long do visits take and is there compensation? How much does it pay? How long is the study and when does it start?
PatientReceived 2+ prior treatments
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