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

Study Overview
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Brief Summary
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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
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Healthy controls (HC) will be studied as outpatient 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 scan along with neurocognitive tasks. Cocaine users will be asked to complete outpatient follow-ups twice a week for up to nine weeks following their inpatient stay.

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

Conditions
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Cocaine Use Disorder, Healthy Controls

Intervention / Treatment
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* Radiation: 11C-UCB-J


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cocaine Use Disorder<br> | Radiation: 11C-UCB-J<br>* 11C-UCB-J PET scan<br>|
| Healthy Control<br> | Radiation: 11C-UCB-J<br>* 11C-UCB-J PET scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group (CUD vs. HC) comparisons in ACC. | Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons in vmPFC. | Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons in mOFC. | Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within subjects (CUD group) comparisons in ACC. | Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in ACC. | Baseline versus 3 weeks after. | 
| Within subjects (CUD group) comparisons in vmPFC. | Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in vmPFC. | Baseline versus 3 weeks after. | 
| Within subjects (CUD group) comparisons in mOFC. | Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in mOFC. | Baseline versus 3 weeks after. | 
| Between-group (CUD vs. HC) of volume of distribution comparisons in ACC. | Between-group comparisons of volume of distribution (VT) in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC. | Between-group comparisons of volume of distribution (VT) in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC. | Between-group comparisons of volume of distribution (VT) in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons of binding potential in ACC. | Between-group comparisons of binding potential (BPND) in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons of binding potential in vmPFC. | Between-group comparisons of binding potential (BPND) in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons of binding potential in mOFC. | Between-group comparisons of binding potential (BPND) in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons of gray matter volume in ACC. | Between-group comparisons of gray matter volume (GMV) in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC. | Between-group comparisons of gray matter volume (GMV) in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | 
| Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC. | Between-group comparisons of gray matter volume (GMV) in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. |