Multi-System Analysis of Opioid Receptor Binding

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study in up to 20 healthy subjects (including 10 females and 10 males) will use [11C]carfentanil whole-body PET imaging to examine the CNS and broader systemic opioid binding and its blockade by the non-selective opioid antagonist naloxone administered parenterally in 2 scan sessions, which can be done the same day or on different days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Carfentanil; Naloxone

Criteria

Inclusion Criteria:

1. Healthy males and females, 18-50 years of age

2. 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.

3. Fluent in English and able to provide written informed consent in English.

Exclusion Criteria:

1. Women who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening and on the day of each of the PET/CT scans.

2. Subjects who report 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.

3. 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.

4. History of or current major DSM-5 Axis 1 psychiatric diagnosis, as identified during psychiatric interview or mental status examination at screening/baseline.

5. History of epilepsy or seizure disorder, head trauma or brain (CNS) tumor as assessed by medical record review and/or self-report

6. A history of substance abuse disorder (SUD) and /or current treatment for a SUD, including nicotine dependence.

7. Self-reported current alcohol consumption that exceeds 14 standard drinks/week for men and 7 standard drinks/week for women.

8. A breath alcohol concentration (BAC) reading > 0.01, a urine toxicology test positive for prohibited drugs or a positive CO breast test at any study visit.

9. Current or use within past 12 months of any medications containing naltrexone or other MOR ligands (e.g., buprenorphine)

10. Current us or recent discontinuation (within 14 days of screening) of the following medications (Participants will be instructed to refrain from using any study-prohibited drugs, though participants will be allowed to take prescription medicines not on the exclusionary list throughout their participation in the study.)

• Any form of smoking cessation medication

• Any medication prescribed to treat alcohol use disorder or heavy drinking

11. Use within the past 12 months of psychotropic medications (antipsychotics, antidepressants, anti-anxiety medications, stimulants or opioid-containing medications for pain for longer than one week).

12. Allergic reaction to any opioid or naloxone

13. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

14. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-report that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study or interfere with distribution of the radiotracer.

Only individuals 18 years or older who can understand and give informed consent will be able to participate in this study. All individuals will be told that their participation is voluntary and they may withdraw from the study at any time. Individuals will also be informed that no matter their decision, their access to clinical care at the University of Pennsylvania or its affiliates will not be affected. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study. The menopausal status of female study participants will be reviewed during the screening process by examining the patient's chart and/or by self-report. All women of child-bearing potential will have a urine pregnancy test prior to injection of [11C]carfentanil.