Cocaine Use Disorder and Cortical Dopamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-02

Study Completion Date

2020-06-01

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

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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.

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

\[C-11\]FLB 457 d-amphetamine

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cocaine dependence

\[C-11\]FLB 457 PET at baseline and post d-amphetamine

Group Type EXPERIMENTAL

d-amphetamine

Intervention Type DRUG

oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

[C-11]FLB 457

Intervention Type RADIATION

PET radiotracer

Controls

\[C-11\]FLB 457 PET at baseline and post d-amphetamine

Group Type EXPERIMENTAL

d-amphetamine

Intervention Type DRUG

oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

[C-11]FLB 457

Intervention Type RADIATION

PET radiotracer

Interventions

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d-amphetamine

oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

Intervention Type DRUG

[C-11]FLB 457

PET radiotracer

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Males or Females 18-40
2. Fulfill Diagnostic and Statistical Manual (DSM-IV) Diagnosis for Cocaine Dependence
3. 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

1. Males or Females 18-40
2. Absence of present or past psychiatric conditions (including alcohol or drug dependence)
3. A negative urine drug screen
4. Medically Healthy

MAJOR EXCLUSIONS

1. Any 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, or drug and alcohol Abuse/Dependence in first-degree relatives

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes