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Multi-System Analysis of Opioid Receptor Binding

NCT05528848 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

Interventions

DRUG

Carfentanil, C-11

Investigational radiotracer to be injected by IV as s a bolus during both study PET/CT scans.

DRUG

Naloxone

Non-selective opioid antagonist injected by IV parenterally during the second study PET/CT scan only.

DRUG

Loperamide Hydrochloride

Loperamide is an FDA- approved, over-the-counter drug for the control and symptomatic relief of acute or chronic diarrhea given orally prior to the optional HC third PET/CT scan only.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528848 on ClinicalTrials.gov