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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA042633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To determine if [C-11]NOP-1A receptor binding (VT) can be altered by an intravenous hydrocortisone (cortisol) challenge through CRF-NOP interactions
Examines changes in [C-11]NOP-1A pharmacokinetics caused by an intravenous hydrocortisone challenge (1 mg/kg)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [C-11]NOP-1A PET Scan conditions | Experimental | Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug |
| ||
| [C-11]NOP-1A |
| Measure | Description | Time Frame |
|---|---|---|
| [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) | Baseline and 3.5 hours post-hydrocortisone |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31706582 | Result | 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. |
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45 subjects screened, 19 assigned to interventions
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| ID | Title | Description |
|---|---|---|
| FG000 | [C-11]NOP-1A PET Scan Conditions | Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition Hydrocortisone [C-11]NOP-1A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [C-11]NOP-1A PET Scan Conditions | Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition Hydrocortisone [C-11]NOP-1A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | [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) | Posted | Mean | Standard Deviation | mL/cm^3 | Baseline and 3.5 hours post-hydrocortisone |
|
|
< 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [C-11]NOP-1A PET Scan Conditions | Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition Hydrocortisone [C-11]NOP-1A |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Narendran | Univesity of Pittsburgh | 412-647-5176 | narendranr@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2018 | Sep 8, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2018 | Sep 8, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Baseline [C-11]NOP-1A scan Post-hydrocortisone [C-11]NOP-1A scan
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |