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[18F]NOS Imaging for Alcoholism (AUD Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
AUD Trial Summary
This trial will assess inflammation in the brain & body of people with alcohol use disorder & healthy volunteers using imaging.
Who is the study for?
This trial is for individuals aged 18 to 65 with alcohol use disorder (AUD) and healthy volunteers, willing to consent and complete study procedures. Excluded are those using certain medications, pregnant or breastfeeding women, people with untreated substance disorders (except nicotine/cannabis), HIV positive individuals, those with serious psychiatric illnesses or conditions that could affect the study's safety or results.Check my eligibility
What is being tested?
[18F]NOS PET/CT scans are being tested to measure brain and whole-body inflammation in up to 90 participants—60 with AUD and 30 healthy volunteers. Each participant will undergo one [18F]NOS PET/CT scan during the study.See study design
What are the potential side effects?
As [18F]NOS is an investigational radiotracer used for imaging purposes rather than a drug treatment, specific side effects related to its use are not detailed here but may include reactions typical of diagnostic imaging agents such as discomfort at injection site or allergic reactions.
AUD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
[18F]NOS uptake (distribution volume) in the brain and other organs in body
Secondary outcome measures
Amount of c-reactive protein (mg/dl) in blood
Amount of magnetic resonance spectroscopy Glutamate levels (in mM) in the brain
Other outcome measures
[18F]NOS uptake (distribution volume) in the brain and other organs in body pre and post treatment with Ibudilast
AUD Trial Design
2Treatment groups
Experimental Treatment
Group I: HV-Healthy VolunteerExperimental Treatment1 Intervention
30 adult men and women between the ages of 18-65 who do not have alcohol use disorder and are a healthy volunteer will be enrolled in this study.
Group II: AUD-Alcohol Use DisorderExperimental Treatment1 Intervention
60 adult men and women who have alcohol use disorder will undergo up to 2 PET/CT scans each approximately 60 minutes of dynamic scanning starting at the time of injection of [18F]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of [18F]NOS.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,119 Total Patients Enrolled
26 Trials studying Alcoholism
3,560 Patients Enrolled for Alcoholism
Jacob Dubroff, MD, PhDPrincipal InvestigatorPerelman School of Medicine, Dept. of Radiology
4 Previous Clinical Trials
249 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using corticosteroids or anti-inflammatory medications.I can avoid taking certain medications like painkillers or antibiotics before MRI and PET scans.I am between 18 and 65 years old.I've had a head injury with unconsciousness over 30 minutes or had a skull fracture or bleeding in the brain.
Research Study Groups:
This trial has the following groups:- Group 1: HV-Healthy Volunteer
- Group 2: AUD-Alcohol Use Disorder
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.
Would I be a suitable candidate for this research project?
"To qualify for this research trial, applicants must have an alcohol use disorder and be of legal age to 65. On top of that, 90 participants are needed in total."
Answered by AI
Is registration for this trial currently open?
"This medical trial, which underwent its last update on August 14th 2023 according to clinicaltrials.gov, is still seeking participants for the study that was initially posted on April 25th of this year."
Answered by AI
Does this test have an age restriction, and if so, what is it?
"As stated in the trial's eligibility requirements, only those aged 18 and above but below 65 are qualified to participate."
Answered by AI
How many individuals have signed up for this experiment thus far?
"Affirmative. As per the details found on clinicaltrials.gov, this trial has been actively recruiting since April 25th 2023 and is seeking 90 patients from one medical centre."
Answered by AI
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