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

Early Phase 1

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Radiation: [C-11]; Drug: NOP-1A

• Registration Number: NCT03448016
• Lead Sponsor: Rajesh Narendran

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-05-27
• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol use disorders	NOP-1A	\[C-11\]NOP-1A PET Scan
Controls	[C-11]	\[C-11\]NOP-1A PET Scan
Alcohol use disorders	[C-11]	\[C-11\]NOP-1A PET Scan
Controls	NOP-1A	\[C-11\]NOP-1A PET Scan

Primary Outcome Measures

Name	Time	Method
[C-11]NOP-1A VT	Baseline	VT-Volume of distribution expressed relative to total plasma

Trial Locations

Locations (1)

University of PIttsburgh PET Facility; 🇺🇸 Pittsburgh, Pennsylvania, United States