Cocaine Use Disorder and Cortical Dopamine

NCT03349606 | Completed Early Phase 1 FDA Drug

• 3 other identifiers: PRO10030625R01DA026472PRO14080588
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Percent change in Binding potential (BPnd)

  DELTA BPnd

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

Study Arms (2)

Cocaine dependence

EXPERIMENTAL

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

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

Controls

EXPERIMENTAL

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

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

Interventions

d-amphetamine DRUG

oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

Cocaine dependence; Controls

[C-11]FLB 457 RADIATION

PET radiotracer

Cocaine dependence; Controls

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or Females 18-40
• Fulfill Diagnostic and Statistical Manual (DSM-IV) Diagnosis for Cocaine Dependence
• \. 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
• Males or Females 18-40
• Absence of present or past psychiatric conditions (including alcohol or drug dependence)
• A negative urine drug screen
• Medically Healthy
• Any medical, psychiatric, co-morbid drug \& alcohol use disorders
• Pregnancy or lactation,
• Contraindications to MRI
• Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
• Family History of a psychotic illness or manic episode, or drug and alcohol Abuse/Dependence in first-degree relatives

Sponsors & Collaborators

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

Study Sites (1)

University of PIttsburgh PET Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor in Radiology

Model Details: \[C-11\]FLB 457 d-amphetamine

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: June 2, 2010
• Primary Completion: September 24, 2019
• Study Completion: June 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)