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

NCT03448016 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: PRO16030103 & PRO13080387R01AA025247
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• [C-11]NOP-1A VT

  VT-Volume of distribution expressed relative to total plasma

  Baseline

Study Arms (2)

Alcohol use disorders

EXPERIMENTAL

\[C-11\]NOP-1A PET Scan

Radiation: [C-11]; Drug: NOP-1A

Controls

EXPERIMENTAL

\[C-11\]NOP-1A PET Scan

Radiation: [C-11]; Drug: NOP-1A

Interventions

[C-11] RADIATION

Radiolabel

Alcohol use disorders; Controls

NOP-1A DRUG

Tracer

Alcohol use disorders; Controls

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rajesh Narendran: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of PIttsburgh PET Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

3-alpha-Hydroxysteroid Dehydrogenase (B-Specific); 3-(2'-fluoro-6',7'-dihydrospiro(piperidine-4,4'-thieno(3,2-c)pyran)-1-yl)-2-(2-fluorobenzyl)-N-methylpropanamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

3-Hydroxysteroid Dehydrogenases; Hydroxysteroid Dehydrogenases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases

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: SPONSOR INVESTIGATOR
• PI Title: Visiting Professor in Radiology

Model Details: \[C-11\]NOP-1A

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: May 27, 2016
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)