drugset / Trial / NCT05528848

Multi-System Analysis of Opioid Receptor Binding

NCT05528848

Phase 1 Active not recruiting 25 enrolled University of Pennsylvania
Non-randomizedSingle-groupOpen-labelOther

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.

Timeline

Start
2022-09-20
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfentanil Diagnostic / imaging agent 370 mbq Intravenous
Subject Naloxone Small molecule 13 ug/kg Intravenous
Background Loperamide Small molecule 4 mg Oral
Background Loperamide Small molecule 30 ml Oral