Cocaine Use Disorder and Cortical Dopamine

Study Overview
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Brief Summary
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The goal of this study is to use [C-11]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure cortical dopamine transmission in cocaine dependent individuals and healthy controls

Detailed Description
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This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with [C-11]FLB 457, in cortical regions of interest in subjects who have a history of cocaine dependence. We hypothesize that cocaine dependence is associated with decreases in dopamine in the prefrontal cortical regions compared to controls. This may explain the impulsivity and cognitive deficits that underlie relapse in this disorder.

Official Title
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Imaging of Cortical Dopamine Transmission in Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: d-amphetamine
* Radiation: [C-11]FLB 457


Participation Criteria
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Eligibility Criteria
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Subjects with Cocaine Dependence INCLUSION CRITERIA Males or Females 18-40 Fulfill Diagnostic and Statistical Manual (DSM-IV) Diagnosis for Cocaine Dependence Medically Healthy MAJOR EXCLUSIONS 1. Major medical, psychiatric, co-morbid drug & alcohol use disorders 2. Pregnancy or lactation, 3. Contraindications to MRI 4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 5. Family History of a psychotic illness or manic episode in first-degree relatives Healthy Subjects INCLUSION CRITERIA Males or Females 18-40 Absence of present or past psychiatric conditions (including alcohol or drug dependence) A negative urine drug screen Medically Healthy MAJOR EXCLUSIONS Any medical, psychiatric, co-morbid drug & alcohol use disorders Pregnancy or lactation, Contraindications to MRI Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year Family History of a psychotic illness or manic episode, or drug and alcohol Abuse/Dependence in first-degree relatives

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: [C-11]FLB 457 d-amphetamine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocaine dependence<br>[C-11]FLB 457 PET at baseline and post d-amphetamine | Drug: d-amphetamine<br>* oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain<br>Radiation: [C-11]FLB 457<br>* PET radiotracer<br>|
| Experimental: Controls<br>[C-11]FLB 457 PET at baseline and post d-amphetamine | Drug: d-amphetamine<br>* oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain<br>Radiation: [C-11]FLB 457<br>* PET radiotracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Binding potential (BPnd) | DELTA BPnd | Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours) |