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Cocaine Use Disorder and Cortical Dopamine

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
d-amphetamine
[C-11]FLB 457
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cocaine Dependence

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of PIttsburgh PET Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cocaine dependence

Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent change in Binding potential (BPnd)
DELTA BPnd

Secondary Outcome Measures

Full Information

First Posted
November 17, 2017
Last Updated
June 1, 2020
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03349606
Brief Title
Cocaine Use Disorder and Cortical Dopamine
Official Title
Imaging of Cortical Dopamine Transmission in Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2, 2010 (Actual)
Primary Completion Date
September 24, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
[C-11]FLB 457 d-amphetamine
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cocaine dependence
Arm Type
Experimental
Arm Description
[C-11]FLB 457 PET at baseline and post d-amphetamine
Arm Title
Controls
Arm Type
Experimental
Arm Description
[C-11]FLB 457 PET at baseline and post d-amphetamine
Intervention Type
Drug
Intervention Name(s)
d-amphetamine
Intervention Description
oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain
Intervention Type
Radiation
Intervention Name(s)
[C-11]FLB 457
Intervention Description
PET radiotracer
Primary Outcome Measure Information:
Title
Percent change in Binding potential (BPnd)
Description
DELTA BPnd
Time Frame
Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of PIttsburgh PET Facility
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cocaine Use Disorder and Cortical Dopamine

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