Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04721418

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Gustavo Angarita, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

11C-UCB-J

Radiation

11C-UCB-J PET scan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcella Mignosa, MD

CONTACT

[email protected]

203 974 7557

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.