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Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study

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Yale University

Status

Enrolling

Conditions

Healthy Controls
Cocaine Use Disorder

Treatments

Radiation: 11C-UCB-J

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04721418
2000029552
1R01DA052454-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.

Full description

Healthy controls (HC) will be studied as outpatients and undergo one MRI and one 11C-UCB-J PET scan, along with neurocognitive tasks. Individuals with Cocaine Use Disorder (CUD) will complete the study as inpatients on our unit and undergo one MRI and two 11C-UCB-J PET scans, along with neurocognitive tasks. Participants will complete sleep studies (to evaluate sleep architecture); the first two nights after admission and the last two nights before discharge. Cocaine users will be asked to complete outpatient follow-ups twice a week for up to nine weeks following their inpatient stay.

Enrollment

80 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 21-60 years
  • Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
  • For females, a negative serum pregnancy test
  • For CUD: DSM-5 criteria for Cocaine Use Disorder and positive urine toxicology showing recent use
  • For HC: Negative urine toxicology

Exclusion criteria

  • DSM-5 criteria for other substance use disorders (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
  • A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID-5)
  • A history of significant and/or uncontrolled medical or neurological illness
  • Current use of psychotropic and/or potentially psychoactive prescription medications
  • Medical contraindications to MRI procedure

Trial design

80 participants in 2 patient groups

Cocaine Use Disorder
Treatment:
Radiation: 11C-UCB-J
Healthy Control
Treatment:
Radiation: 11C-UCB-J

Trial contacts and locations

1

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Central trial contact

Marcella Mignosa, MD

Data sourced from clinicaltrials.gov

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