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Tau PET Imaging for Opioid Use Disorder
Phase < 1
Recruiting
Led By Ilya Nasrallah, 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the brain chemistry of people with opioid use disorder and those without, using PET/CT scans.
Who is the study for?
Adults aged 18-60 with opioid use disorder (OUD) are eligible for this trial. It includes those who have had an overdose treated with naloxone in the past year, those without such a history, and healthy controls without OUD or recent opioid use. Participants must be on stable medication for OUD for at least 30 days and provide informed consent.
What is being tested?
The study is testing [18F]PI-2620 PET/CT imaging to measure tau protein uptake in the brain across three groups: individuals with OUD who've overdosed, those with OUD who haven't overdosed, and healthy controls.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the injection of the tracer [18F]PI-2620, reactions to PET/CT scan contrast materials if used, and general risks associated with radiation exposure from imaging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Standardized uptake value ratio (SUVr)
Secondary study objectives
MRI cortical thickness
MRI cortical volume
Other study objectives
Neurocognitive test results
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tau PET/CTExperimental Treatment1 Intervention
PET/CT imaging will be used to evaluate the uptake of tau in the brain using the investigational radiotracer \[18F\]PI-2620. Each subject will have one \[18F\]PI-2620 positron emission tomography/computed tomography (PET/CT) scan performed.
Participants will undergo approximately 30 minutes of static PET scanning of the brain and body starting approximately 45 minutes post injection of \[18F\]PI-2620. All images will be corrected for scatter and measured photon attenuation and reconstructed using standard reconstruction techniques. Standardized uptake value ratio (SUVr), the ratio of regional to reference uptake, will be calculated with cerebellum as reference, where NFTs are generally not present in neurodegenerative disorders, hence likely not in OUD.
Subjects in all three groups undergo a brain MRI including a structural MRI functional reactivity to an episodic memory task, and undergo a comprehensive neurocognitive battery.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,561 Total Patients Enrolled
Yale UniversityOTHER
1,924 Previous Clinical Trials
3,031,598 Total Patients Enrolled
Ilya Nasrallah, MD, PhDPrincipal InvestigatorUniveristy of Pennsylvania
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is over 350 pounds.You have never had an overdose, according to your own report or medical records.I have a history of epilepsy or seizures.My organs are not working properly.I do not have any health conditions that could make participating unsafe for me.I am between 18-60, healthy, with no history of substance abuse except for cannabis, tobacco, or nicotine, and I haven't used opioids in the last 30 days.I have been on a stable dose of medication for opioid use disorder for at least 30 days.I prefer opioids for my treatment.I am between 18 and 60 years old.You understand that this study is experimental and agree to participate by signing a written consent form. You will follow the guidelines set by the hospital and government for this study.I have had an opioid overdose reversed by naloxone in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Tau PET/CT
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.
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