[C-11]NPA PET-amphetamine in Cocaine Use Disorders

NCT05011760 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY20060171 (Aim 2)R01DA026472
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• DELTA binding potential relative to non displaceable uptake (BPND)

  DELTA BPND is the change in BPND from the baseline PET scan to post-amphetamine PET scan that will be acquired 2.5 to 3 hours after d-amphetamine administration (0.5 mg/Kg, oral)

  Baseline, and 2.5 to 3 hours post-amphetamine

Study Arms (1)

PET

EXPERIMENTAL

\[C-11\]NPA PET Scan

Radiation: Baseline [C-11]NPA PET Scan; Drug: d-amphetamine; Radiation: Post-amphetamine [C-11]NPA PET Scan

Interventions

Baseline [C-11]NPA PET Scan RADIATION

Radiotracer

PET

d-amphetamine DRUG

Oral, 0.5 mg/Kg

PET

Post-amphetamine [C-11]NPA PET Scan RADIATION

Radiotracer

PET

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females between 18 and 55 years old
• Fulfil DSM-5 criteria for cocaine use disorder
• No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)
• 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);
• Not currently on prescription medical or psychotropic medications
• 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
• Not currently pregnant or breastfeeding
• No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines
• No metallic objects in the body that are contraindicated for MRI
• No baseline BP ≥ 140/90 and/or HR ≥ 100.
• No first-degree relative with an MI or stroke prior to middle age
• No first-degree relative with psychosis or mania.
• Completed a baseline \[11C\]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

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; Dextroamphetamine

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Rajesh Narendran

  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: Single group, correlational analyses

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: January 31, 2021
• 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)