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

Cocaine Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721418
• Other study ID #: 2000029552
• Secondary ID: 1R01DA052454-01A
• Status: Recruiting
• Start date: July 20, 2021
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Marcella Mignosa, MD
• Phone: 203 974 7557
• Email: marcella.mignosa[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Healthy Controls

Intervention

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

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.