CClinicalTrials.gg
CompletedNCT03448016Updated Jul 11, 2022

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

An Early Phase 1 interventional study of [C-11] and NOP-1A in Alcohol Use Disorder, sponsored by Rajesh Narendran. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Rajesh Narendran · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Alcohol Use Disorder
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

[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
04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Alcohol use disorders

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

    Radiation: [C-11] · Drug: NOP-1A

  • Experimental
    Controls

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

    Radiation: [C-11] · Drug: NOP-1A

Interventions

  • Radiation[C-11]

    Radiolabel

  • DrugNOP-1A

    Tracer

05

What researchers measure

Primary outcomes

  1. [C-11]NOP-1A VT

    VT-Volume of distribution expressed relative to total plasma

    Time frame: Baseline

06

Study locations

1 site
  • University of PIttsburgh PET Facility
    Pittsburgh, Pennsylvania 15213, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03448016
Lead sponsor
Rajesh Narendran
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Rajesh Narendran (Visiting Professor in Radiology, University of Pittsburgh) — Sponsor-investigator
First posted
Feb 27, 2018
Start date
May 27, 2016
Primary completion
Mar 30, 2021
Completion
Mar 30, 2021
Last update
Jul 11, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion