Recruiting
Early Phase 1

C-11 NPA

Sponsor:

Rajesh Narendran

Code:

NCT05011760

Conditions

Cocaine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Baseline [C-11]NPA PET Scan

d-amphetamine

Post-amphetamine [C-11]NPA PET Scan

Study Details

Brief summary:

This study uses \[11C\]NPA positron emission tomography (PET) and a d-amphetamine challenge to image amphetamine induced dopamine release in the striatum in subjects with cocaine use disorders (CUD). Amphetamine-induced dopamine release data from this study will be correlated with \[11C\]NOP-1A VT measured at baseline in the midbrain. \[11C\]NOP-1A PET data will be used from aim 1 (see, Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

Conditions

Cocaine Use Disorder

Study ID

NCT05011760

Start date

Jan 31, 2021

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: Not accepted

Inclusion Criteria:

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, and MDMA 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
10. No baseline BP ≥ 140/90 and/or HR ≥ 100.
11. No first-degree relative with an MI or stroke prior to middle age
12. No first-degree relative with psychosis or mania.
13. Completed a baseline \[11C\]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PET

\[C-11\]NPA PET Scan

Interventions

Baseline [C-11]NPA PET Scan

Radiotracer

d-amphetamine

Oral, 0.5 mg/Kg

Post-amphetamine [C-11]NPA PET Scan

Radiotracer

Primary outcome measure

  • DELTA binding potential relative to non displaceable uptake (BPND) [ Time Frame: Baseline, and 2.5 to 3 hours post-amphetamine ]

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

  • [C-11]NOP-1A, [C-11]NPA , nociceptive opioid peptide receptors, dopamine release

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.