Effects of Opioid Use Disorder and Non-fatal Overdose on Tau Pathology; a [18F]PI-2620 PET/CT Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The investigators plan to enroll up to 60 adult subjects in this study. There will be three groups of up to 20 subjects each in this study. Group 1: individuals with OUD and a history of at least one opioid-related OD in the past 5 years that required naloxone treatment reversal: OUD/OD+ Group 2: individuals with OUD without a lifetime history of opioid-related OD OUD/OD- Group 3: Healthy controls without a lifetime OUD: HCs 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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⁃ OUD OD- group:

• 18-60 years-old

• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

• Participants meet for lifetime OUD and are currently in medication-assisted treatment for OUD, which must include being on a stable dose of medication for at least 30 days prior to the screening visit.

• No lifetime history of OD per self-report, Drug Overdose Questionnaire, and/or medical record review.

⁃ OUD OD+ group:

• 18-60 years-old

• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

• Participants meet for lifetime OUD and are currently in medication-assisted treatment for OUD, which must include being on a stable dose of medication for at least 30 days prior to the screening visit.

• A history of at least 1 opioid OD that required naloxone reversal that occurred up to 5 years prior to study enrollment, as per self-report, Drug Overdose Questionnaire, and/or medical record review.

⁃ Healthy Control (HC) group:

• 18-60 years-old

• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

• Must have never met lifetime history for Alcohol Use Disorder, Substance Use Disorder --other than cannabis, tobacco or nicotine use disorder (as per DSM-5) and not used an opioid for any reason in the 30 days prior to screening by self-report, medical record review, and urine drug testing at screening.

• Must provide a negative urine drug screen on the day of the screening, MRI and PET scan visits for all substances (other than cannabis).

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Erin Schubert
erin.schubert@pennmedicine.upenn.edu
215-573-6569
Backup
Hannah Straughn
hannah.straughn@pennmedicine.penn.edu
215-573-6442
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2027-12
Participants
Target number of participants: 60
Treatments
Experimental: Tau PET/CT
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.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov