CRF - Nociceptin Receptor Interactions

Healthy Clinical Trial

Official title:

In Vivo Imaging of Corticotropin-releasing Factor - Nociceptin Receptor Interactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302416
• Other study ID #: PRO16030242
• Secondary ID: R21DA042633
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Examines changes in [C-11]NOP-1A pharmacokinetics caused by an intravenous hydrocortisone challenge (1 mg/kg)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Males or females between 18 and 40 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Hydrocortisone

Radiation:
• [C-11]NOP-1A

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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 [(11)C]NOP-1A to Nociceptin Receptors: A Novel Imaging Paradigm to Study the — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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