[C-11]NOP-1A and Alcohol Use Disorder

NCT ID: NCT03448016

Last Updated: 2022-07-11

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-27

Study Completion Date

2021-03-30

Brief Summary

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

Detailed Description

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This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans

Conditions

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Alcohol 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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Alcohol use disorders

\[C-11\]NOP-1A PET Scan

Group Type EXPERIMENTAL

[C-11]

Intervention Type RADIATION

Radiolabel

NOP-1A

Intervention Type DRUG

Tracer

Controls

\[C-11\]NOP-1A 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
2. Fulfill DSM5 diagnosis for alcohol use disorder
3. Medically Healthy


1. Males or females
2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
3. Medically Healthy

Exclusion Criteria

1. Pregnancy or lactation
2. Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
4. Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain

\[B\]Healthy controls


1. Pregnancy of lactation
2. Medical, psychiatric or comorbid 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 a 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 psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Rajesh Narendran

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Narendran

Visiting Professor in Radiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of PIttsburgh PET Facility

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA025247

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO16030103 & PRO13080387

Identifier Type: -

Identifier Source: org_study_id

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