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

NCT03348384 — Early Phase 1, Completed, 49 participants, University of Pittsburgh

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Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders

Registry	NCT03348384
Status	Completed
Phase	Early Phase 1
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	49 (Actual)
Sponsor	University of Pittsburgh (Other); collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Cocaine Use Disorder
Interventions	[C-11], NOP-1A (Radiation, drug)
Dates	start 2014-10-30, primary completion 2019-02-20, completion 2019-02-20, first posted 2017-11-20, last updated 2019-08-05
Locations	1 site in United States

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Cocaine use disorders	Experimental	Radiation: [C-11]; Drug: NOP-1A	PET scan
Controls	Experimental	Radiation: [C-11]; Drug: NOP-1A	PET scan

[C-11] (Radiation): Radiolabel
NOP-1A (Drug): Tracer

+Outcome measures

Primary outcomes

[C-11]NOP-1A VT [Baseline]: VT-volume of distribution expressed relative to total plasma

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

\[A\]Cocaine use disorders

Inclusion criteria:

1. Males or Females 18-50
2. Fulfill DSM-5 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.

+Locations (1)

Facility	City	Country	Status
University of Pittsburgh	Pittsburgh, Pennsylvania	United States

+Funding

NIH grants: R01DA026472