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

Yale University80 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cocaine Use Disorder Healthy Controls

Interventions

11C-UCB-JRADIATION

11C-UCB-J PET scan

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Between-group (CUD vs. HC) comparisons in ACC.

Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC.

Time frame: 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.

Time frame: 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.

Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline versus 3 weeks after.

Central Contacts

Marcella Mignosa, MD

CONTACT

203 974 7557 marcella.mignosa@yale.edu

Data from ClinicalTrials.gov

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