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NCT03349606 Clinical Trial

Cocaine Use Disorder and Cortical Dopamine

Cocaine Dependence Clinical Trial

Official title:
Imaging of Cortical Dopamine Transmission in Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03349606
Other study ID # PRO10030625
Secondary ID R01DA026472PRO14
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 2, 2010
Est. completion date June 1, 2020

Study information
Verified date June 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 1, 2020
Est. primary completion date September 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of PIttsburgh PET Facility Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

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