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OpenTrials
Completed

NCT Number: NCT03302416

CRF - 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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

[C-11]NOP-1A

Radiation

Primary outcomes

  1. [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)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2017
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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