Back to results[C-11]NOP-1A and Alcohol Use Disorder
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[C-11]
NOP-1A
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use Disorder
Eligibility Criteria
[A] Alcohol use disorders (AUD)
Inclusion Criteria:
- Males or Females
- Fulfill DSM5 diagnosis for alcohol use disorder
- Medically Healthy
Exclusion Criteria:
- Pregnancy or lactation
- 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)
- Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
- Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
- Currently on any psychotropic medications that can influence nociceptin transmission in the brain
[B]Healthy controls
Inclusion Criteria:
- Males or females
- Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
- Medically Healthy
Exclusion Criteria:
- Pregnancy of lactation
- Medical, psychiatric or comorbid drug/alcohol use disorders
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- Currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year
- Currently on any psychotropic medications that can influence nociceptin transmission in the brain
- Family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
Sites / Locations
- University of PIttsburgh PET Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Alcohol use disorders
Controls
Arm Description
[C-11]NOP-1A PET Scan
[C-11]NOP-1A PET Scan
Outcomes
Primary Outcome Measures
[C-11]NOP-1A VT
VT-Volume of distribution expressed relative to total plasma
Secondary Outcome Measures
Full Information
NCT ID
NCT03448016
First Posted
February 21, 2018
Last Updated
July 8, 2022
Sponsor
Rajesh Narendran
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03448016
Brief Title
[C-11]NOP-1A and Alcohol Use Disorder
Official Title
Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rajesh Narendran
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
[C-11]NOP-1A
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol use disorders
Arm Type
Experimental
Arm Description
[C-11]NOP-1A PET Scan
Arm Title
Controls
Arm Type
Experimental
Arm Description
[C-11]NOP-1A PET Scan
Intervention Type
Radiation
Intervention Name(s)
[C-11]
Intervention Description
Radiolabel
Intervention Type
Drug
Intervention Name(s)
NOP-1A
Intervention Description
Tracer
Primary Outcome Measure Information:
Title
[C-11]NOP-1A VT
Description
VT-Volume of distribution expressed relative to total plasma
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
[A] Alcohol use disorders (AUD)
Inclusion Criteria:
Males or Females
Fulfill DSM5 diagnosis for alcohol use disorder
Medically Healthy
Exclusion Criteria:
Pregnancy or lactation
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)
Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
Currently on any psychotropic medications that can influence nociceptin transmission in the brain
[B]Healthy controls
Inclusion Criteria:
Males or females
Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
Medically Healthy
Exclusion Criteria:
Pregnancy of lactation
Medical, psychiatric or comorbid drug/alcohol use disorders
Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
Currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year
Currently on any psychotropic medications that can influence nociceptin transmission in the brain
Family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
Facility Information:
Facility Name
University of PIttsburgh PET Facility
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
[C-11]NOP-1A and Alcohol Use Disorder
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