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Completed

NCT Number: NCT03448016

[C-11]NOP-1A and Alcohol Use Disorder

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

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of PIttsburgh PET Facility

Pittsburgh, Pennsylvania, 15213, United States

About this study

This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans

Who can participate

Healthy volunteers accepted: Yes

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

[A] Alcohol use disorders (AUD)

Inclusion criteria

  • Males or Females
  • Fulfill DSM5 diagnosis for alcohol use disorder
  • Medically Healthy

Exclusion criteria

  • Pregnancy or lactation
  • Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
  • Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
  • Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
  • Currently on any psychotropic medications that can influence nociceptin transmission in the brain

[B]Healthy controls

Inclusion criteria

  • Males or females
  • Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
  • Medically Healthy

Exclusion criteria

  • Pregnancy of lactation
  • Medical, psychiatric or comorbid drug/alcohol use disorders
  • Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  • Currently employed as a 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 psychotic disorder, manic episode, drug and alcohol use disorder 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

Rajesh Narendran

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2018
Registry last updated
Jul 11, 2022

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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