Imaging CRF X NOP Interactions in CUD

NCT05008146 | Recruiting Early Phase 1 FDA Drug

• 3 other identifiers: STUDY20060171 (Aim 1)R01DA026472STUDY19110156
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses \[11C\]NOP-1A positron emission tomography (PET) and a hydrocortisone challenge to image the interaction between nociceptive opioid peptide (NOP) receptors and cortisol/corticotrophin releasing factor (CRF) in subjects with cocaine use disorders (CUD) and matched healthy controls (HC). It will also examine whether alterations in CRF x NOP interactions predict relapse in subjects with CUD.

Conditions

Cocaine Use Disorder

Keywords

Cocaine use disorder; [C-11]NOP-1A PET; Nociceptive opioid peptide receptors

Outcome Measures

Primary Outcomes (1)

• DELTA VT

  VT is the volumes of distribution expressed relative to total plasma ligand concentration; Delta VT is the change in VT from baseline to 3-hours post-hydrocortisone.

  Baseline, and 3 hours post-hydrocortisone

Study Arms (1)

PET

EXPERIMENTAL

\[C-11\]NOP-1A

Radiation: Baseline [C-11]NOP-1A PET Scan; Drug: Hydrocortisone; Radiation: Post-hydrocortisone [C-11]NOP-1A PET Scan

Interventions

Baseline [C-11]NOP-1A PET Scan RADIATION

Radiotracer

PET

Hydrocortisone DRUG

Intravenous, 1mg/Kg

PET

Post-hydrocortisone [C-11]NOP-1A PET Scan RADIATION

Radiotracer

PET

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Cocaine use disorders (CUD) 1. Males or females between 18 and 55 years old 2. Fulfil DSM-5 criteria for cocaine use disorder 3. No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,) 4. No current abuse (six months) of opiates, sedative-hypnotics, amphetamines, MDMA, etc., as well as moderate to severe alcohol or cannabis use (twice a week). Nicotine use will be quantified and controlled between groups using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991); 5. Not currently on prescription medical or psychotropic medications 6. No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia as assessed by a complete medical history and physical 7. Not currently pregnant or breastfeeding 8. No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines 9. No metallic objects in the body that are contraindicated for MRI Healthy Controls (HC) 1. Males or females between 18 and 55 years old 2. No present or past DSM-5 disorders (other than nicotine dependence) 3. Criteria 5 to 9 as listed previously.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rajesh Narendran: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

BaseLine dental cement; Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Rajesh Narendran, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Narendran, MD

CONTACT

4126475176; narendranr@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology and Psychiatry

Model Details: Cocaine Use disorder and Healthy control groups will receive same interventions

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 17, 2021
• Study Start: December 31, 2020
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)