Tau PET Imaging for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Ilya Nasrallah, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Pennsylvania

Must be taking: Medication-assisted treatment

Disqualifiers: HIV, Epilepsy, Serious psychiatric disorder, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are in the OUD groups, you must be on a stable dose of your medication-assisted treatment for at least 30 days before the screening visit. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the study team.

What data supports the effectiveness of the treatment 18F-PI-2620 PET/CT for opioid use disorder?

The research highlights the importance of PET imaging in understanding opioid receptors, which are crucial in substance dependence. Although not directly related to 18F-PI-2620, the studies show that PET imaging can provide valuable insights into brain changes in opioid use disorder, suggesting potential benefits in using similar imaging techniques for treatment evaluation. ^{1 2 3 4 5}

How does this treatment differ from other treatments for opioid use disorder?

This treatment is unique because it uses tau PET imaging to study brain changes in opioid use disorder, focusing on the opioid receptor system, which is crucial in addiction. Unlike standard treatments that primarily target symptoms, this approach aims to understand the underlying brain mechanisms, potentially leading to more targeted therapies. ^{1 5 6 7 8}

Research Team

Ilya Nasrallah, MD, PhD

Principal Investigator

Univeristy of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

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 criteria for lifetime OUD and are currently in medication-assisted treatment for OUD with a stable dose of medication for at least 30 days prior to screening, 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 criteria for lifetime OUD and are currently in medication-assisted treatment for OUD with a stable dose of medication for at least 30 days prior to screening, A history of at least 1 opioid OD that required naloxone reversal up to 5 years prior to study enrollment per self-report, Drug Overdose Questionnaire, and/or medical record review

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.

Exclusion Criteria

My weight is over 350 pounds.

I have a history of epilepsy or seizures.

Contraindications to MRI

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Testing

Participants undergo PET/CT imaging to evaluate tau uptake and a comprehensive neurocognitive battery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and testing

8 weeks

Treatment Details

Interventions

• 18F-PI-2620 PET/CT (Radiopharmaceutical)

Trial Overview 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.

Participant Groups

Group I: Tau PET/CT Experimental Treatment 1 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 Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2118

Patients Recruited

45,270,000+

Yale University

Collaborator

Trials

1963

Patients Recruited

3,046,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain opioid receptor binding in early abstinence from alcohol dependence and relationship to craving: an [11C]diprenorphine PET study. Williams, TM., Davies, SJ., Taylor, LG., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Imaging. Hammers, A., Lingford-Hughes, A.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classics in Neuroimaging: Shedding Light on Opioid Receptors with Positron Emission Tomography Imaging. Kaur, T., Wiesner, N., Kilbourn, MR., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and Evaluation of a 64Cu-Conjugate, a Selective &#948;-Opioid Receptor Positron Emission Tomography Imaging Agent. Pirisedigh, A., Blais, V., Ait-Mohand, S., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional cerebral metabolism alterations and functional connectivity in individuals with opioid use disorder: An integrated resting-state PET/fMRI study. Jin, L., Yuan, M., Zhang, W., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of opioid receptors in the central nervous system. Henriksen, G., Willoch, F.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blunted endogenous opioid release following an oral dexamphetamine challenge in abstinent alcohol-dependent individuals. Turton, S., Myers, JF., Mick, I., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging opiate receptors in the human brain with positron emission tomography. Potential applications for drug addiction research. Sadzot, B., Mayberg, HS., Frost, JJ.[2016]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Brain opioid receptor binding in early abstinence from alcohol dependence and relationship to craving: an [11C]diprenorphine PET study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Opioid Imaging. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Classics in Neuroimaging: Shedding Light on Opioid Receptors with Positron Emission Tomography Imaging. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Synthesis and Evaluation of a 64Cu-Conjugate, a Selective &#948;-Opioid Receptor Positron Emission Tomography Imaging Agent. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Regional cerebral metabolism alterations and functional connectivity in individuals with opioid use disorder: An integrated resting-state PET/fMRI study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Imaging of opioid receptors in the central nervous system. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Blunted endogenous opioid release following an oral dexamphetamine challenge in abstinent alcohol-dependent individuals. [2023]

8. Belgium pubmed.ncbi.nlm.nih.gov

Imaging opiate receptors in the human brain with positron emission tomography. Potential applications for drug addiction research. [2016]