Cocaine Use Disorder and Cortical Dopamine

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT03349606
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 120
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: d-amphetamine; Radiation: [C-11]FLB 457	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: [C-11]FLB 457 d-amphetamine[C-11]FLB 457 d-amphetamine
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Imaging of Cortical Dopamine Transmission in Cocaine Dependence
• Actual Study Start Date: Jun 2, 2010
• Actual Primary Completion Date: Sep 24, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cocaine dependence [C-11]FLB 457 PET at baseline and post d-amphetamine	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
Experimental: Controls [C-11]FLB 457 PET at baseline and post d-amphetamine	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

Outcome Measures

Primary Outcome Measures

1. Percent change in Binding potential (BPnd) [Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours)]

   DELTA BPnd

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of PIttsburgh PET Facility	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajesh Narendran, Visiting Professor in Radiology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03349606
• Other Study ID Numbers: PRO10030625; R01DA026472; PRO14080588
• First Posted: Nov 21, 2017
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Cocaine-Related Disorders; Amphetamine; Dextroamphetamine; FLB 457

Study Results

No Results Posted as of Jun 4, 2020