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

NCT ID: NCT03348384

Last Updated: 2019-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-30

Study Completion Date

2019-02-20

Brief Summary

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

Detailed Description

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

Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

\[C-11\]NOP-1A
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cocaine use disorders

PET scan

Group Type EXPERIMENTAL

[C-11]

Intervention Type RADIATION

Radiolabel

NOP-1A

Intervention Type DRUG

Tracer

Controls

PET scan

Group Type EXPERIMENTAL

[C-11]

Intervention Type RADIATION

Radiolabel

NOP-1A

Intervention Type DRUG

Tracer

Interventions

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[C-11]

Radiolabel

Intervention Type RADIATION

NOP-1A

Tracer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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


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

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


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Narendran

Visiting Professor in Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA026472

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO14080588

Identifier Type: -

Identifier Source: org_study_id

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