ClinicalTrials.gg
CompletedNCT03348384Updated Aug 5, 2019

[11C]NOP-1A and Cocaine Use Disorders

An Early Phase 1 interventional study of [C-11] and NOP-1A in Cocaine Use Disorder, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by University of Pittsburgh · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Feb 2019, 7 years 8 months ago, and no results have been posted to the registry.
  • Registered 3 years after the study started (first participant enrolled Oct 2014, registered Nov 2017).
Phase
Early Phase 1
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

Read the detailed description

This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.

02

Conditions studied

  • Cocaine Use Disorder
03

In context

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

[A]Cocaine use disorders

Inclusion criteria:

  1. Males or Females 18-50
  2. Fulfill Diagnosis for Cocaine use disorder
  3. Medically Healthy

Major exclusion criteria:

  1. Pregnancy or lactation
  2. Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use)
  3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
  4. Currently employed as 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 (e.g., morphine, suboxone, SSRIs, etc.)

[B] Healthy controls

Inclusion criteria:

  1. Males or Females 18-50
  2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
  3. A negative urine drug screen
  4. Medically Healthy

Major exclusion criteria

  1. Pregnancy or lactation
  2. Medical, psychiatric or 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 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 a psychotic disorder, manic episode, drug use disorders in first-degree relatives.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

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

Study arms

  • Experimental
    Cocaine use disorders

    PET scan

    Radiation: [C-11] · Drug: NOP-1A

  • Experimental
    Controls

    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
    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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03348384
Responsible party
Rajesh Narendran (Visiting Professor in Radiology, University of Pittsburgh) — Principal investigator
First posted
Nov 20, 2017
Start date
Oct 30, 2014
Primary completion
Feb 20, 2019
Completion
Feb 20, 2019
Last update
Aug 5, 2019

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 Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NOP-1A

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