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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

From the registry’s dates

  • Primary completion was Mar 2021, 5 years 7 months ago, and no results have been posted to the registry.
  • Registered 1 year 8 months after the study started (first participant enrolled May 2016, registered Feb 2018).
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

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03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's enrollment of 54 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Rajesh Narendran is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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
05

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

06

What researchers measure

Primary outcomes

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

    VT-Volume of distribution expressed relative to total plasma

    Time frame: Baseline

07

Study locations

1 site
  • University of PIttsburgh PET Facility
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2016 to primary completion in Mar 2021, 58 months.

Of 63 non-industry phase 1 interventional studies under Alcoholism, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's 58 months is above that.

Counting every sponsor, half of 75 studies reached it within 28 months; a quarter within 19 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2018
First posted
Feb 27, 2018
StartActual
May 27, 2016
Primary completionActual
Mar 30, 2021
CompletionActual
Mar 30, 2021
Last update
Jul 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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