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Completed

NCT Number: NCT03348384

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

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

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

[A]Cocaine use disorders

Inclusion criteria

  • Males or Females 18-50
  • Fulfill DSM-5 Diagnosis for Cocaine use disorder
  • Medically Healthy

Major exclusion criteria:

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

[B] Healthy controls

Inclusion criteria

  • Males or Females 18-50
  • Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
  • A negative urine drug screen
  • Medically Healthy

Major exclusion criteria

  • Pregnancy or lactation
  • Medical, psychiatric or drug & alcohol use disorders
  • Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  • Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
  • Currently on any psychotropic medications that can influence nociceptin transmission in the brain
  • Family history of a psychotic disorder, manic episode, drug use disorders in first-degree relatives.

Treatment and study plan

[C-11]

Radiation

Radiolabel

NOP-1A

Drug

Tracer

Primary outcomes

  1. [C-11]NOP-1A VT

    Time frame: Baseline

    VT-volume of distribution expressed relative to total plasma

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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