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CompletedNCT03349606Updated Jun 4, 2020

Cocaine Use Disorder and Cortical Dopamine

An Early Phase 1 interventional study of d-amphetamine and [C-11]FLB 457 in Cocaine Dependence, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by University of Pittsburgh · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cocaine Dependence
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Cocaine dependence

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

    Drug: d-amphetamine · Radiation: [C-11]FLB 457

  • Experimental
    Controls

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

    Drug: d-amphetamine · Radiation: [C-11]FLB 457

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

05

What researchers measure

Primary outcomes

  1. Percent change in Binding potential (BPnd)

    DELTA BPnd

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

06

Study locations

1 site
  • University of PIttsburgh PET Facility
    Pittsburgh, Pennsylvania 15213, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03349606
Lead sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Rajesh Narendran (Visiting Professor in Radiology, University of Pittsburgh) — Principal investigator
First posted
Nov 21, 2017
Start date
Jun 2, 2010
Primary completion
Sep 24, 2019
Completion
Jun 1, 2020
Last update
Jun 4, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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