CRF - Nociceptin Receptor Interactions

University of Pittsburgh

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: Hydrocortisone; Radiation: [C-11]NOP-1A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03302416

R21DA042633 (U.S. NIH Grant/Contract)

PRO16030242

Details and patient eligibility

About

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

Full description

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Radiation: [C-11]NOP-1A

Drug: Hydrocortisone