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

Alcohol Use Disorder Clinical Trial

Official title:

Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448016
• Other study ID #: PRO16030103 & PRO13080387
• Secondary ID: R01AA025247
• Status: Completed
• Phase: Early Phase 1
• Start date: May 27, 2016
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

[A] Alcohol use disorders (AUD)

Inclusion Criteria:

1. Males or Females

2. Fulfill DSM5 diagnosis for alcohol use disorder

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

Inclusion Criteria:

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 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Radiation:
• [C-11]
Radiolabel

Drug:
• NOP-1A
Tracer

Locations

Country	Name	City	State
United States	University of PIttsburgh PET Facility	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rajesh Narendran	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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