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Trial · Interventional

CompletedEarly phase 1Results postedRegistry data

CRF - Nociceptin Receptor Interactions

NCTNCT03302416 (opens ClinicalTrials.gov in a new tab)Other idPRO16030242Other idR21DA042633
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Early phase 1
Enrollment
19 participants (actual)
Sponsor
University of Pittsburgh · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Jun 2016
Primary completion
1 Jun 2019
Completion
1 Jun 2019
First posted
5 Oct 2017
Last update posted
27 Oct 2020
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph Early 1

    CRF - Nociceptin Receptor Interactions

    NCT03302416

    1 Jun 2016 to 1 Jun 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • HydrocortisoneDrug
  • [C-11]NOP-1ARadiation

Arms1

  • Experimental

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

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and 3.5 hours post-hydrocortisone

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 3.5 hours post-hydrocortisone

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

GroupValue (mL/cm^3)Spread
Baseline Participants16.31.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
[C-11]NOP-1A PET Scan ConditionsBaseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition Hydrocortisone \[C-11\]NOP-1A0 / 190 / 190 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultFlanigan 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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