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

Recruiting

• Conditions: Cocaine Use Disorder; Healthy Controls
• Interventions: Radiation: 11C-UCB-J

• Registration Number: NCT04721418
• Lead Sponsor: Yale University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-07-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cocaine Use Disorder	11C-UCB-J	-
Healthy Control	11C-UCB-J	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Between-group (CUD vs. HC) comparisons of binding potential in ACC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of binding potential (BPND) in ACC.
Between-group (CUD vs. HC) comparisons of binding potential in vmPFC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of binding potential (BPND) in vmPFC.
Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of gray matter volume (GMV) in vmPFC.
Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of gray matter volume (GMV) in mOFC.
Within subjects (CUD group) comparisons in mOFC.	Baseline versus 3 weeks after.	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.
Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of volume of distribution (VT) in ACC.
Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of volume of distribution (VT) in vmPFC.
Between-group (CUD vs. HC) comparisons of binding potential in mOFC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of binding potential (BPND) in mOFC.
Within subjects (CUD group) comparisons in ACC.	Baseline versus 3 weeks after.	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.
Within subjects (CUD group) comparisons in vmPFC.	Baseline versus 3 weeks after.	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.
Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of volume of distribution (VT) in mOFC.
Between-group (CUD vs. HC) comparisons of gray matter volume in ACC.	CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.	Between-group comparisons of gray matter volume (GMV) in ACC.

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States