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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03348384
Other study ID # PRO14080588
Secondary ID R01DA026472
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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