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
• 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
• 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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

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)