Healthy
Conditions
Brief summary
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)
Interventions
DRUGHydrocortisone
RADIATION[C-11]NOP-1A
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Baseline \[C-11\]NOP-1A scan Post-hydrocortisone \[C-11\]NOP-1A scan
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | 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) |
Countries
United States
Participant flow
Pre-assignment details
45 subjects screened, 19 assigned to interventions
Participants by arm
| Arm | Count |
|---|---|
| [C-11]NOP-1A PET Scan Conditions Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition
Hydrocortisone
\[C-11\]NOP-1A | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | [C-11]NOP-1A PET Scan Conditions |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 25 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 77 Kilograms STANDARD_DEVIATION 16 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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)
Time frame: Baseline and 3.5 hours post-hydrocortisone
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Amygdala/baseline | 16.3 mL/cm^3 | Standard Deviation 1.9 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Amygdala/post-hydrocortisone | 18.7 mL/cm^3 | Standard Deviation 2.8 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Hippocampus/baseline | 11.6 mL/cm^3 | Standard Deviation 1.3 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Hippocampus/post-hydrocortisone | 13.3 mL/cm^3 | Standard Deviation 2 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Midbrain/baseline | 9.4 mL/cm^3 | Standard Deviation 1 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Midbrain/post-hydrocortisone | 10.6 mL/cm^3 | Standard Deviation 1.6 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Vental striatum/baseline | 15.1 mL/cm^3 | Standard Deviation 1.7 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Ventral striatum/post-hydrocortisone | 17.1 mL/cm^3 | Standard Deviation 2.1 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Caudate/baseline | 12.7 mL/cm^3 | Standard Deviation 1.4 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Caudate/post-hydrocortisone | 14.0 mL/cm^3 | Standard Deviation 1.9 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Putamen/baseline | 14.3 mL/cm^3 | Standard Deviation 1.6 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Putamen/post-hydrocortisone | 16.0 mL/cm^3 | Standard Deviation 2 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | dorsolateralPFC/baseline | 14.4 mL/cm^3 | Standard Deviation 1.8 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | dorsolateralPFC/post-hydrocortisone | 16.4 mL/cm^3 | Standard Deviation 2.4 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Orbital frontal cortex/baseline | 14.9 mL/cm^3 | Standard Deviation 1.8 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Orbital frontal cortex/post-hydrocortisone | 17.1 mL/cm^3 | Standard Deviation 2.6 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | MedialPFC/baseline | 14.3 mL/cm^3 | Standard Deviation 1.8 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | MedialPFC/post-hydrocortisone | 16.2 mL/cm^3 | Standard Deviation 2.4 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | anterior cigulate/baseline | 14.6 mL/cm^3 | Standard Deviation 1.7 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | anterior cingulate/post-hydrocortisone | 16.6 mL/cm^3 | Standard Deviation 2.6 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Cerebellum/baseline | 8.2 mL/cm^3 | Standard Deviation 0.9 |
| Baseline Participants | [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration | Cerebellum/post-hydrocortisone | 9.3 mL/cm^3 | Standard Deviation 1.3 |
p-value: 0.005Linear mixed model