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

University of Pittsburgh

Status and phase: Completed; Early Phase 1

Conditions: Cocaine Use Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03348384

R01DA026472 (U.S. NIH Grant/Contract)

PRO14080588

Details and patient eligibility

About

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

Full description

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

[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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Cocaine use disorders

Experimental group

Description:

PET scan

Treatment:

Radiation: [C-11]

Drug: NOP-1A

Controls

Experimental group

Description:

PET scan

Treatment:

Radiation: [C-11]

Drug: NOP-1A