HealthyEarly Phase 1NCT03302416

CRF - Nociceptin Receptor Interactions

A Early Phase 1 study testing Hydrocortisone and [C-11]NOP-1A in people with Healthy, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Hydrocortisone and [C-11]NOP-1A
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2016to 1 Jun 2019
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males or females between 18 and 40 years old

Who cannot join

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;

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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

Read the detailed description

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

Conditions: Healthy
Being tested: Hydrocortisone, [C-11]NOP-1A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydrocortisoneDrug
[C-11]NOP-1ARadiation

Study groups in NCT03302416
Study group	Role	What they receive
[C-11]NOP-1A PET Scan conditions	Experimental	Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition Receives: Drug: Hydrocortisone; Radiation: [C-11]NOP-1A

What is being measured

The primary outcome is the main question the study is designed to answer.

[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)
Measured: Baseline and 3.5 hours post-hydrocortisone

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20161 Jun 2019

First posted5 Oct 2017
Study start1 Jun 2016
Primary completion1 Jun 2019
Study completion1 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: Baseline \[C-11\]NOP-1A scan Post-hydrocortisone \[C-11\]NOP-1A scan
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03302416
Sponsor's protocol ID: PRO16030242
Other IDs: R21DA042633
Status last verified: Oct 2020
First submitted: 29 Sep 2017
Last updated: 27 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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 [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.
PubMed 31706582

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Imaging of Corticotropin-releasing Factor - Nociceptin Receptor Interactions
ClinicalTrials.gov ID: NCT03302416
Acronym / sponsor ID: PRO16030242
Conditions: Healthy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Jun 2016 (actual)
Primary completion: 1 Jun 2019 (actual)
Study completion: 1 Jun 2019 (actual)
First posted: 5 Oct 2017 (actual)
Results: Posted 27 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Baseline [C-11]NOP-1A scan Post-hydrocortisone [C-11]NOP-1A scan

Arm	Type	Receives
[C-11]NOP-1A PET Scan conditions	Experimental	Drug: Hydrocortisone, Radiation: [C-11]NOP-1ABaseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Males or females between 18 and 40 years old

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrocortisone	Drug	[C-11]NOP-1A PET Scan conditions
[C-11]NOP-1A	Radiation	[C-11]NOP-1A PET Scan conditions

Primary outcome

[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)

Results and safety

Results posted to the registry on 27 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
[C-11]NOP-1A PET Scan Conditions	19	19

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

Time frame: Baseline and 3.5 hours post-hydrocortisone. Mean (Standard Deviation). Unit: mL/cm^3

Measure	Baseline Participants n = 19
Amygdala/baseline	16.3 (1.9)
Amygdala/post-hydrocortisone	18.7 (2.8)
Hippocampus/baseline	11.6 (1.3)
Hippocampus/post-hydrocortisone	13.3 (2.0)
Midbrain/baseline	9.4 (1.0)
Midbrain/post-hydrocortisone	10.6 (1.6)
Vental striatum/baseline	15.1 (1.7)
Ventral striatum/post-hydrocortisone	17.1 (2.1)

Baseline Participants: p = 0.005, Linear mixed model

Adverse events

Time frame: < 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
[C-11]NOP-1A PET Scan Conditions	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31706582Flanigan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hydrocortisone and [C-11]NOP-1A in people with Healthy, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration (time frame: Baseline and 3.5 hours post-hydrocortisone). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.