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

August 24, 2026 updated by: Yale University
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Between-group (CUD vs. HC) comparisons in ACC.
Time Frame: 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.
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons in vmPFC.
Time Frame: 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.
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons in mOFC.
Time Frame: 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.
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Within subjects (CUD group) comparisons in ACC.
Time Frame: 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.
Baseline versus 3 weeks after.
Within subjects (CUD group) comparisons in vmPFC.
Time Frame: 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.
Baseline versus 3 weeks after.
Within subjects (CUD group) comparisons in mOFC.
Time Frame: 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.
Baseline versus 3 weeks after.
Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
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.
Time Frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of gray matter volume (GMV) in mOFC.
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep studies
Time Frame: Baseline versus 3 weeks after.
Investigators will explore the association between synaptic density in the mPFC (measured by VT/fP, with 11C-UCB-J PET) and sleep architecture (measured by slow wave [N3] sleep and total sleep time [TST], using a sleep study device, e.g., polysomnography [PSG]), among subjects with CUD, within 1 week of abstinence and 3 weeks later.
Baseline versus 3 weeks after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gustavo Angarita, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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