CRF - Nociceptin Receptor Interactions

October 2, 2020 updated by: Rajesh Narendran, University of Pittsburgh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [C-11]NOP-1A PET Scan conditions
Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition
Drug: Hydrocortisone
Radiation: [C-11]NOP-1A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
Time Frame: 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)
Baseline and 3.5 hours post-hydrocortisone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 3, 2017

First Posted (Actual)

October 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16030242
  • R21DA042633 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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