[11C]NOP-1A and Cocaine Use Disorders

Overview

The goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use disorders and controls.

Full Title of Study: “Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 20, 2019

Detailed Description

This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.

Interventions

  • Radiation: [C-11]
    • Radiolabel
  • Drug: NOP-1A
    • Tracer

Arms, Groups and Cohorts

  • Experimental: Cocaine use disorders
    • PET scan
  • Experimental: Controls
    • PET scan

Clinical Trial Outcome Measures

Primary Measures

  • [C-11]NOP-1A VT
    • Time Frame: Baseline
    • VT-volume of distribution expressed relative to total plasma

Participating in This Clinical Trial

[A]Cocaine use disorders Inclusion criteria:

1. Males or Females 18-50 2. Fulfill DSM-5 Diagnosis for Cocaine use disorder 3. Medically Healthy Major exclusion criteria:

1. Pregnancy or lactation 2. Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use) 3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan 4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain (e.g., morphine, suboxone, SSRIs, etc.) [B] Healthy controls Inclusion criteria:

1. Males or Females 18-50 2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders) 3. A negative urine drug screen 4. Medically Healthy Major exclusion criteria 1. Pregnancy or lactation 2. Medical, psychiatric or drug & alcohol use disorders 3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan 4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain 6. Family history of a psychotic disorder, manic episode, drug use disorders in first-degree relatives.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rajesh Narendran, Visiting Professor in Radiology – University of Pittsburgh

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