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

July 8, 2022 updated by: Rajesh Narendran

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of PIttsburgh PET Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

[A] Alcohol use disorders (AUD)

Inclusion Criteria:

  1. Males or Females
  2. Fulfill DSM5 diagnosis for alcohol use disorder
  3. Medically Healthy

Exclusion Criteria:

  1. Pregnancy or lactation
  2. 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)
  3. Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
  4. Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
  5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain

[B]Healthy controls

Inclusion Criteria:

  1. Males or females
  2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
  3. Medically Healthy

Exclusion Criteria:

  1. Pregnancy of lactation
  2. Medical, psychiatric or comorbid 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 a 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 psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol use disorders
[C-11]NOP-1A PET Scan
Radiation: [C-11]
Radiolabel
Drug: NOP-1A
Tracer
Experimental: Controls
[C-11]NOP-1A PET Scan
Radiation: [C-11]
Radiolabel
Drug: NOP-1A
Tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[C-11]NOP-1A VT
Time Frame: Baseline
VT-Volume of distribution expressed relative to total plasma
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajesh Narendran

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2016

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16030103 & PRO13080387
  • R01AA025247 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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