Recruiting
Early Phase 1

CRF & NOP

Sponsor:

Rajesh Narendran

Code:

NCT05008146

Conditions

Cocaine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

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

Hydrocortisone

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

Study Details

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

Study ID

NCT05008146

Start date

Dec 31, 2020

Status verified date

Jul, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PET

\[C-11\]NOP-1A

Interventions

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

Radiotracer

Hydrocortisone

Intravenous, 1mg/Kg

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

Radiotracer

Primary outcome measure

  • DELTA VT [ Time Frame: Baseline, and 3 hours post-hydrocortisone ]

Central Contacts and Locations

Central contacts

Rajesh Narendran, MD

4126475176narendranr@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

Rajesh Narendran

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rajesh Narendran on 2026-07-06.