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

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

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder; Healthy Controls
• Intervention / Treatment: Radiation: 11C-UCB-J

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Marcella Mignosa, MD; Phone Number: 203 974 7557; Email: marcella.mignosa@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Connecticut Mental Health Center
      • Contact: Gustavo Angarita, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

One group will have current Cocaine Use Disorder, the other group will be Healthy Controls

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control	Radiation: 11C-UCB-J; 11C-UCB-J PET scan
Cocaine Use Disorder	Radiation: 11C-UCB-J; 11C-UCB-J PET scan

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 2000029552; 1R01DA052454-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No