Cocaine Use Disorder and Cortical Dopamine

University of Pittsburgh

Status and phase: Completed; Early Phase 1

Conditions: Cocaine Dependence

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03349606

R01DA026472 (U.S. NIH Grant/Contract)

PRO10030625

PRO14080588

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

4. 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cocaine dependence

Experimental group

Description:

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

Treatment:

Radiation: [C-11]FLB 457

Drug: d-amphetamine

Controls

Experimental group

Description:

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

Treatment:

Radiation: [C-11]FLB 457

Drug: d-amphetamine