Opioid-Related DisordersEarly Phase 1NCT05651516
Tau PET Imaging in Opioid Use Disorder
A Early Phase 1 study testing 18F-PI-2620 PET/CT in people with Opioid-Related Disorders, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- 18F-PI-2620 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 2 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- HIV infection confirmed by an on-site rapid HIV test at screening. HIV affect neurocognitive function, even in otherwise asymptomatic individuals, which can confound the results of MRI testing.
- The urine drug screening \& pregnancy test (for women of child-bearing potential) at the screening visit, MRI visit, and PET/CT scan visits must be negative for pregnancy (all groups) or will be deemed ineligible to participate. Participants in the healthy control group with a positive drug screen will be ineligible.
- At screening, the participant's weight is >350 lb.
- Self-reported claustrophobia, which in the opinion of an investigator would interfere with acquisition of the structural MRI required for PET co-registration, and/or the PET scan itself.
- Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible). An MRI screening form will be completed during screening to identify contraindications.
- Screening lab values that indicate significant organ dysfunction that in the opinion of an investigator could compromise participant safety or successful participation in the study.
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- History of epilepsy or seizure disorder (that are not a result of substance use or substance withdrawal in OUD+ groups) as assessed by medical record review or self-report.
- History of head trauma that in the opinion of an investigator may interfere with the uptake of applicable radiotracer as assessed by medical record review or self-report.
- Current serious psychiatric disorder (bipolar disorder, schizophrenia, psychotic disorder, eating disorder, or major depressive disorder with suicidal ideation or psychotic features) identified by medical record review, clinical examination or structured psychiatric interview that could interfere with study participation or make it hazardous for the participant or staff to perform study procedures.
- Self-reported heavy daily use of psychoactive substances in the past 30 days (prior to the screening visit), such as stimulants, cocaine, but not including nicotine, caffeine, cannabis (or opioids in the OUD groups) that could interfere with study performance.
- Not able to provide a breath alcohol level of 0.000 (tested with handheld breath analyzer) at the screening, MRI and/or PET scan visits.
- Inability to tolerate imaging procedures as determined by an investigator or treating physician
- Any current medical condition, illness, or disorder assessed by medical record review and/or self-report that is considered by a physician or investigator to potentially compromise participant safety or their successful participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effects of Opioid Use Disorder and Non-fatal Overdose on Tau Pathology; a [18F]PI-2620 PET/CT Study
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.
Read the detailed description
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.
The investigators will draw up to 60 mL of venous blood prior to injection that will be used to measure peripheral blood markers of phosphorylated tau, inflammation, and ApoE genotyping. The results of these research tests will not be given to the subject, will not be included in the medical record and will not be used in the subject's clinical management.
Additional measures will be collected: measures of substance use and related behaviors, psychological and subjective measures, neurocognitive measures and OUD-related health outcomes for correlation with the imaging results.
- Conditions
- Opioid-Related Disorders
- Being tested
- 18F-PI-2620 PET/CT
- Keywords
- Tau, PET/CT
- Medical subject headings
- Opioid-Related Disorders, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PI-2620 PET/CTDrug
Also called PI-2620
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.
| Study group | Role | What they receive |
|---|---|---|
| Tau PET/CT | Experimental | 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. Receives: Drug: 18F-PI-2620 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value ratio (SUVr),
- [18F]PI-2620PET SUVr regional uptake (occipital cortex, medial parietal/posterior cingulate cortex, temporoparietal cortex, medial temporal lobe, frontal lobes).
Measured: 8 weeks
Secondary outcomes (2)
MRI cortical volume
MRI cortical volume
Measured: 8 weeks
MRI cortical thickness
MRI cortical thickness
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start21 Sep 2023
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The analyses for the three aims will use analysis of variance to test for group differences among the three groups (OUD/OD+, OUD/OD-, HC).
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Ilya Nasrallah, MD, PhD, Principal investigator, Univeristy of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651516
- Sponsor's protocol ID
- 852095
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Opioid Use Disorder and Non-fatal Overdose on Tau Pathology; a [18F]PI-2620 PET/CT Study
- ClinicalTrials.gov ID
- NCT05651516
- Acronym / sponsor ID
- 852095
- Conditions
- Opioid-Related Disorders
- Keywords
- Tau, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators will draw up to 60 mL of venous blood prior to injection that will be used to measure peripheral blood markers of phosphorylated tau, inflammation, and ApoE genotyping. The results of these research tests will not be given to the subject, will not be included in the medical record and will not be used in the subject's clinical management.
Additional measures will be collected: measures of substance use and related behaviors, psychological and subjective measures, neurocognitive measures and OUD-related health outcomes for correlation with the imaging results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The analyses for the three aims will use analysis of variance to test for group differences among the three groups (OUD/OD+, OUD/OD-, HC).
| Arm | Type | Receives |
|---|---|---|
| Tau PET/CT | Experimental | Drug: 18F-PI-2620 PET/CTPET/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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
- 18-60 years-old
Key exclusion criteria (13 listed)
- HIV infection confirmed by an on-site rapid HIV test at screening. HIV affect neurocognitive function, even in otherwise asymptomatic individuals, which can confound the results of MRI testing.
- The urine drug screening \& pregnancy test (for women of child-bearing potential) at the screening visit, MRI visit, and PET/CT scan visits must be negative for pregnancy (all groups) or will be deemed ineligible to participate. Participants in the healthy control group with a positive drug screen will be ineligible.
- At screening, the participant's weight is >350 lb.
- Self-reported claustrophobia, which in the opinion of an investigator would interfere with acquisition of the structural MRI required for PET co-registration, and/or the PET scan itself.
- Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible). An MRI screening form will be completed during screening to identify contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PI-2620 PET/CTAlso: PI-2620PET/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. | Drug | Tau PET/CT |
Primary outcome
Standardized uptake value ratio (SUVr),
Time frame: 8 weeks
• [18F]PI-2620PET SUVr regional uptake (occipital cortex, medial parietal/posterior cingulate cortex, temporoparietal cortex, medial temporal lobe, frontal lobes).
2 secondary outcomes
MRI cortical volume
Time frame: 8 weeks
MRI cortical thickness
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Nasrallah, MD, PhD principal investigator
Univeristy of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-PI-2620 PET/CT in people with Opioid-Related Disorders, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value ratio (SUVr), (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.