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NCT05528848 · ClinicalTrials.gov registry record · Phase 1
Multi-System Analysis of Opioid Receptor Binding
A Phase 1 study of Healthy and Opioid Use Disorder, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05528848: Recruiting Phase 1 study of Healthy and Opioid Use Disorder, sponsored by University of Pennsylvania.
NCT05528848 is a Phase 1 study of Healthy and Opioid Use Disorder that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 60 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05528848, a Phase 1 study of Healthy and Opioid Use Disorder, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will enroll up to 60 adults (including 30 females and 30 males) in three cohorts of up to 20 subjects each. In all three groups, \[11C\]carfentanil whole-body PET imaging will be used to examine the central nervous system (CNS) and broader systemic opioid binding in an initial scan session. In the two groups not receiving standard of care medication assisted treatment (MAT) for opioid use disorder (OUD) the effects on \[11C\]carfentanil binding potential of the blockade of opioid binding by the non-selective opioid antagonist naloxone administered parenterally in a second scan session will also be examined. If two scans are completed they can be done on the same day or on different days.
Primary Outcome
Measure MOR BPND following the administration of \[11C\]carfentanil alone in 5 brain regions of interest (ROIs) relevant to addiction (the subgenual anterior cingulate, ventral pallidum, amygdala, nucleus accumbens, and dorsal striatum), spinal cord (key role in transmitting pain signals) and organs outside the central nervous system (CNS) that contain mu-opioid receptors (e.g., the gastrointestinal tract, heart).
Conditions Studied
Interventions
- DRUG Loperamide Hydrochloride
- DRUG Naloxone
- DRUG Carfentanil, C-11
Study Locations (1)
Pennsylvania
- University of Pennsylvania, Perelman School of Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What NCT05528848 shows while recruiting
NCT05528848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Loperamide Hydrochloride is the first listed.
NCT05528848 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05528848 about?
NCT05528848 is a clinical study titled "Multi-System Analysis of Opioid Receptor Binding". This study will enroll up to 60 adults (including 30 females and 30 males) in three cohorts of up to 20 subjects each. In all three groups, \[11C\]carfentanil whole-body PET imaging will be used to examine the central nervous system (CNS) and broader systemic opioid binding in an initial scan sessio...
What is the current status of trial NCT05528848?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-09-20. Estimated completion is 2026-09.
What conditions does trial NCT05528848 study?
This clinical trial studies the following conditions: Healthy, Opioid Use Disorder.
What interventions are being tested in trial NCT05528848?
The interventions under investigation include: Loperamide Hydrochloride (DRUG), Naloxone (DRUG), Carfentanil, C-11 (DRUG).
Who is sponsoring clinical trial NCT05528848?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05528848 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
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05528848's enrollment target sits among peer trials
60 369th of 1090 higher than 689 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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