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Cocaine Use Disorder and Cortical Dopamine

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ClinicalTrials.gov Identifier: NCT03349606
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rajesh Narendran, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: d-amphetamine Radiation: [C-11]FLB 457 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: [C-11]FLB 457 d-amphetamine
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Imaging of Cortical Dopamine Transmission in Cocaine Dependence
Actual Study Start Date : June 2, 2010
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Cocaine dependence
[C-11]FLB 457 PET at baseline and post d-amphetamine
Drug: d-amphetamine
oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

Radiation: [C-11]FLB 457
PET radiotracer

Experimental: Controls
[C-11]FLB 457 PET at baseline and post d-amphetamine
Drug: d-amphetamine
oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

Radiation: [C-11]FLB 457
PET radiotracer




Primary Outcome Measures :
  1. Percent change in Binding potential (BPnd) [ Time Frame: Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours) ]
    DELTA BPnd



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349606


Contacts
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Contact: Rajesh Narendran, MD narendranr@upmc.edu

Locations
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United States, Pennsylvania
University of PIttsburgh PET Facility Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rajesh Narendran       narendranr@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute on Drug Abuse (NIDA)

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Responsible Party: Rajesh Narendran, Visiting Professor in Radiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03349606     History of Changes
Other Study ID Numbers: PRO10030625
R01DA026472 ( U.S. NIH Grant/Contract )
PRO14080588 ( Other Identifier: University of Pittsburgh )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Dopamine
FLB 457
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Protective Agents
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Dopamine Antagonists