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NCT05651516 · ClinicalTrials.gov registry record · Early Phase 1
Tau PET Imaging in Opioid Use Disorder
A Early Phase 1 study of Opioid-Related Disorders, sponsored by University of Pennsylvania.
- Active
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05651516: Active Early Phase 1 study of Opioid-Related Disorders, sponsored by University of Pennsylvania.
NCT05651516 is a Early Phase 1 study of Opioid-Related Disorders that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 12 participants, below the 347-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05651516, a Early Phase 1 study of Opioid-Related Disorders, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
• \[18F\]PI-2620PET SUVr regional uptake (occipital cortex, medial parietal/posterior cingulate cortex, temporoparietal cortex, medial temporal lobe, frontal lobes).
Conditions Studied
Interventions
- DRUG 18F-PI-2620 PET/CT
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2027-12 |
| Phase | Early Phase 1 |
What the registry record for NCT05651516 still lists
NCT05651516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 347-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Opioid-Related Disorders appearing as the primary indexed condition, and to 1 intervention - of which 18F-PI-2620 PET/CT is the first listed.
NCT05651516 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05651516 about?
NCT05651516 is a clinical study titled "Tau PET Imaging in Opioid Use Disorder". 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: i...
What is the current status of trial NCT05651516?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2023-09-21. Estimated completion is 2027-12.
What conditions does trial NCT05651516 study?
This clinical trial studies the following conditions: Opioid-Related Disorders.
What interventions are being tested in trial NCT05651516?
The interventions under investigation include: 18F-PI-2620 PET/CT (DRUG).
Who is sponsoring clinical trial NCT05651516?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05651516 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05651516's enrollment target sits among peer trials
12 43rd of 47 higher than 3 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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