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

Cocaine Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348384
• Other study ID #: PRO14080588
• Secondary ID: R01DA026472
• Status: Completed
• Phase: Early Phase 1
• Start date: October 30, 2014
• Est. completion date: February 20, 2019

Study information

• Verified date: August 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

[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.

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Disease

Intervention

Radiation:
• [C-11]
Radiolabel

Drug:
• NOP-1A
Tracer

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[C-11]NOP-1A VT	VT-volume of distribution expressed relative to total plasma	Baseline