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

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

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

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Radiation: [C-11]; Drug: NOP-1A

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

[A]Cocaine use disorders

Inclusion criteria:

1. Males or Females 18-50
2. Fulfill DSM-5 Diagnosis for Cocaine use disorder
3. Medically Healthy

Major exclusion criteria:

1. Pregnancy or lactation
2. Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as 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 (e.g., morphine, suboxone, SSRIs, etc.)

[B] Healthy controls

Inclusion criteria:

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

Major exclusion criteria

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cocaine use disorders; PET scan	Radiation: [C-11]; Radiolabel; Drug: NOP-1A; Tracer
EXPERIMENTAL: Controls; 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	VT-volume of distribution expressed relative to total plasma	Baseline

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2014
• Primary Completion (ACTUAL): February 20, 2019
• Study Completion (ACTUAL): February 20, 2019

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (ACTUAL): November 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: PRO14080588 (University of Pittsburgh); R01DA026472 (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