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Recruiting NCT04721418

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

— Observational Cocaine Use Disorder Healthy Controls

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 11C-UCB-J.
Who it may be relevant to
Registry conditions: Cocaine Use Disorder, Healthy Controls. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Detailed 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.

Interventions

  • Radiation 11C-UCB-J
    11C-UCB-J PET scan

Primary outcome measures

  • Between-group (CUD vs. HC) comparisons in ACC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons in vmPFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons in mOFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
Secondary outcome measures (12)
  • Within subjects (CUD group) comparisons in ACC. [Time frame: Baseline versus 3 weeks after.]
  • Within subjects (CUD group) comparisons in vmPFC. [Time frame: Baseline versus 3 weeks after.]
  • Within subjects (CUD group) comparisons in mOFC. [Time frame: Baseline versus 3 weeks after.]
  • Between-group (CUD vs. HC) of volume of distribution comparisons in ACC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons of binding potential in ACC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons of binding potential in vmPFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons of binding potential in mOFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons of gray matter volume in ACC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]
  • Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC. [Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Connecticut Mental Health Center — New Haven

Identifiers

NCT: NCT04721418 · 2000029552 · 1R01DA052454-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗