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

NCT03348384 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: PRO14080588R01DA026472
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine 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)

Cocaine use disorders

EXPERIMENTAL

PET scan

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

Controls

EXPERIMENTAL

PET scan

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

Interventions

[C-11] RADIATION

Radiolabel

Cocaine use disorders; Controls

NOP-1A DRUG

Tracer

Cocaine use disorders; Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

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

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: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor in Radiology

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

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: October 30, 2014
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)