CRF - Nociceptin Receptor Interactions

NCT03302416 | Completed Early Phase 1 Results

• 2 other identifiers: PRO16030242R21DA042633
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if \[C-11\]NOP-1A receptor binding (VT) can be altered by an intravenous hydrocortisone (cortisol) challenge through CRF-NOP interactions

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration

  VT is the volume of distribution expressed relative to total plasma concentration. This is defined consistent with that reported in Consensus nomenclature for in vivo imaging of reversibly binding radioligands (Reference: J Cereb Blood Flow Metab 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493)

  Baseline and 3.5 hours post-hydrocortisone

Study Arms (1)

[C-11]NOP-1A PET Scan conditions

EXPERIMENTAL

Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition

Drug: Hydrocortisone; Radiation: [C-11]NOP-1A

Interventions

Hydrocortisone DRUG

[C-11]NOP-1A PET Scan conditions

[C-11]NOP-1A RADIATION

[C-11]NOP-1A PET Scan conditions

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females between 18 and 40 years old

You may not qualify if:

• Current DSM-5 psychiatric disorders
• Binge drinking as defined in NIAAA criteria in the past month
• Recreational abuse of opiates, sedative-hypnotics, cocaine, amphetamines, MDMA, and PCP, as well as cannabis use
• Currently on any prescription medical or psychotropic medication;
• Current or past severe medical, endocrine, cardiovascular, immunological or neurological illnesses
• Currently pregnant or breast-feeding;
• History of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past twelve months
• Metallic objects in the body that are contraindicated for MRI;
• First-degree relative with psychosis or mood disorders

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Flanigan M, Tollefson S, Himes ML, Jordan R, Roach K, Stoughton C, Lopresti B, Mason NS, Ciccocioppo R, Narendran R. Acute Elevations in Cortisol Increase the In Vivo Binding of [11C]NOP-1A to Nociceptin Receptors: A Novel Imaging Paradigm to Study the Interaction Between Stress- and Antistress-Regulating Neuropeptides. Biol Psychiatry. 2020 Mar 15;87(6):570-576. doi: 10.1016/j.biopsych.2019.09.013. Epub 2019 Sep 25.

  PMID: 31706582 RESULT

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Rajesh Narendran
• Organization: Univesity of Pittsburgh

narendranr@upmc.edu

412-647-5176

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor in Radiology

Model Details: Baseline \[C-11\]NOP-1A scan Post-hydrocortisone \[C-11\]NOP-1A scan

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 5, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)