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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Standardized uptake value ratio (SUVr)
Secondary outcome measures
MRI cortical thickness
MRI cortical volume
Other outcome measures
Neurocognitive test results

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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,227 Total Patients Enrolled
Yale UniversityOTHER
1,853 Previous Clinical Trials
2,738,501 Total Patients Enrolled
Ilya Nasrallah, MD, PhDPrincipal InvestigatorUniveristy of Pennsylvania

Media Library

Tau PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT05651516 — Phase < 1
Opioid Use Disorder Research Study Groups: Tau PET/CT
Opioid Use Disorder Clinical Trial 2023: Tau PET/CT Highlights & Side Effects. Trial Name: NCT05651516 — Phase < 1
Tau PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651516 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to seniors for this research project?

"The age range for individuals that can enroll in this trial is 18 to 60. Additionally, there are 22 trials specifically targeting minors and 243 studies focusing on participants 65 years of age or older."

Answered by AI

Are there vacancies within this experiment for participants?

"From the information presented on clinicaltrials.gov, it is apparent that this medical trial has ceased recruiting for now; initial posting was on December 1st 2022 and its last update took place 12 days later. Nevertheless, there are 295 other studies in progress at present which include patient enrolment."

Answered by AI

Can I join the research initiative based on my current status?

"This clinical trial seeks 60 individuals aged 18 to 60, who have a history of opioid abuse. Admittance into the study also necessitates that participants are informed about its investigational nature and can provide written consent; currently receiving treatment for OUD on a stable dose for 30 days prior to screening; specify opioids as their preferred drug with no lifetime record of OD or opioid use disorder (as per DSM-5) in the past 30 days via self-report and medical records review; plus documented evidence of an opioid overdose requiring naloxone reversal occurring between 1 - 12 months preceding enrollment."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
Tau PET Imaging in Opioid Use Disorder
2023. "Tau PET Imaging in Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05651516.
All > Opioid Dependence
~37 spots leftby Dec 2025
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