What is d-amphetamine studying for cocaine use disorder?

This study evaluates how d-amphetamine affects dopamine release in the brain of people with cocaine use disorder. Researchers aim to understand brain chemical changes linked to stress and relapse by using PET scans and amphetamine challenges. The lead sponsor for this clinical trial is Rajesh Narendran.

Who may be eligible for this cocaine use disorder clinical trial?

Adults aged 18 to 55 with a diagnosis of cocaine use disorder and no other major psychiatric or addictive disorders may be eligible. Both males and females can participate. Participants must not currently use certain drugs or medications and must be in good medical health. Please review eligibility criteria for more details.

Is there any cost to participate in this cocaine use disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Early Phase 1

Age: 18Years - 55Years

All Genders

ID05011760

C-11NPA PET-amphetamine in Cocaine Use Disorders Aim 2

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

Participants Needed

Research Sites

N/A

Total Duration

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 brains 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-11NPA PET scan to measure brain receptor activity, followed by oral administration of d-amphetamine at 0.5 mgKg to stimulate dopamine release. After 2.5 to 3 hours, a second C-11NPA 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

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

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

Research Team

Rajesh Narendran, MD

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