Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
ID05011760

[C-11]NPA PET-amphetamine in Cocaine Use Disorders (Aim 2)

Led by Rajesh Narendran · Updated on 2025-06-05

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Rajesh Narendran

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating cocaine use disorder (CUD), a chronic condition marked by frequent relapses and abstinence periods. This early phase 1 study aims to understand the brain's chemical changes related to stress and relapse by examining dopamine release after amphetamine use and its link to the nociceptin opioid peptide receptor (NOP) system, which helps counteract stress effects in the brain. The study explores how this system may fail in people with CUD, potentially leading to relapse. Participants will undergo a series of scans and drug challenges. They will first have a baseline [C-11]NPA PET scan to measure brain receptor activity, followed by oral administration of d-amphetamine at 0.5 mg/Kg to stimulate dopamine release. After 2.5 to 3 hours, a second [C-11]NPA PET scan will be performed to observe changes in dopamine activity. This imaging approach helps link brain receptor expression to dopamine release in relevant brain regions. Throughout the study, participants will be closely monitored with PET scans before and after amphetamine administration. Researchers will measure changes in dopamine receptor binding potential to evaluate brain responses. Additional eligibility requirements include medical history reviews, physical exams, and ensuring no interfering medications or conditions. The primary outcome is the change in binding potential relative to non-displaceable uptake measured at baseline and post-amphetamine, with follow-up planned over twelve weeks to relate findings to relapse risk.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females between 18 and 55 years old
  • Meet DSM-5 criteria for cocaine use disorder
  • No other current DSM-5 psychiatric or addictive disorders
  • No current abuse of opiates, sedative-hypnotics, amphetamines, MDMA, or moderate to severe alcohol or cannabis use in last six months
  • Not currently taking prescription medical or psychotropic medications
  • No history of severe medical, endocrine, or neurological illnesses
  • Not currently pregnant or breastfeeding
  • No significant radioactivity exposure in past year exceeding guidelines
  • No metallic objects in the body that contraindicate MRI
  • Blood pressure below 140/90 and heart rate below 100 at baseline
  • No first-degree relative with early myocardial infarction or stroke
  • No first-degree relative with psychosis or mania
  • Completed a baseline [11C]NOP-1A PET scan in Aim 1
Not Eligible

You will not qualify if you...

  • Outside the age range of 18 to 55 years
  • Presence of any other current DSM-5 psychiatric or addictive disorders
  • Current abuse of opiates, sedative-hypnotics, amphetamines, MDMA, or moderate to severe alcohol or cannabis use
  • Currently on prescription medical or psychotropic medications
  • History of severe medical, endocrine, or neurological illnesses including glaucoma, seizure disorders, hypertension, or hypercholesterolemia
  • Pregnant or breastfeeding
  • Significant recent exposure to radioactivity exceeding guidelines
  • Presence of metallic objects contraindicated for MRI
  • Baseline blood pressure 140/90 or higher, or heart rate 100 or higher
  • First-degree relative with early myocardial infarction or stroke
  • First-degree relative with psychosis or mania
  • Not completed a baseline [11C]NOP-1A PET scan in Aim 1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline PET Scan

Duration - 1 day

Participants undergo a baseline [C-11]NPA PET scan to measure nociceptive opioid peptide receptor activity before receiving amphetamine.

1 visit (in-person)

d-amphetamine Administration and Post-amphetamine PET Scan

Duration - Same day as baseline scan

Participants receive oral d-amphetamine followed by a post-amphetamine [C-11]NPA PET scan to assess changes in receptor activity after drug administration.

1 visit (in-person)

12-Week Follow-up Monitoring

Duration - 12 weeks

Participants are monitored for up to 12 weeks to track relapse and neurochemical changes after PET scans and amphetamine exposure.

Periodic follow-up visits

Trial Site Locations

Total: 1 location

1

University of PIttsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

Loading map...

Research Team

R

Rajesh Narendran, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

Similar Trials

Aberrant Synaptic Plasticity in Cocaine Use Disorder Using 1...

Cocaine Use Disorder

Actively Recruiting

1 location

Targeting Immune Inflammation in Cocaine Use Disorder: A Hum...

Cocaine Use Disorder

Actively Recruiting

1 location

Cognitive Reappraisal for Mitigating Incubation of Cocaine C...

Cocaine Use Disorder

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here