Cocaine Use Disorder and Cortical Dopamine

Imaging of Cortical Dopamine Transmission in Cocaine Dependence

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03349606

Enrollment

Registered

2017-11-21

Start date

2010-06-02

Completion date

2020-06-01

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependence

Brief summary

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

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.

Interventions

DRUGd-amphetamine

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

RADIATION[C-11]FLB 457

PET radiotracer

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

Subjects with Cocaine Dependence 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 Healthy Subjects INCLUSION CRITERIA 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026