CRF - Nociceptin Receptor Interactions

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Hydrocortisone; Radiation: [C-11]NOP-1A

• Registration Number: NCT03302416
• Lead Sponsor: University of Pittsburgh

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

Detailed Description

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

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Results First Submitted: 2020-09-05
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-02
• Last Update Submitted: 2020-10-02
• Results First Posted: 2020-10-27
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[C-11]NOP-1A PET Scan conditions	[C-11]NOP-1A	Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition
[C-11]NOP-1A PET Scan conditions	Hydrocortisone	Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition

Primary Outcome Measures

Name	Time	Method
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration	Baseline and 3.5 hours post-hydrocortisone	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)

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States