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Completed

NCT Number: NCT03349606

Cocaine Use Disorder and Cortical Dopamine

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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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of PIttsburgh PET Facility

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

d-amphetamine

Drug

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

[C-11]FLB 457

Radiation

PET radiotracer

Primary outcomes

  1. Percent change in Binding potential (BPnd)

    Time frame: Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours)

    DELTA BPnd

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Imaging of Cortical Dopamine Transmission in Cocaine Dependence

Important dates

Study start
2010
Primary completion
2019
Study completion
2020
First posted
Nov 21, 2017
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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