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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04721418
Collaborator
(none)
80
1
58.4
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: 11C-UCB-J

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Actual Study Start Date :
Jul 20, 2021
Anticipated Primary Completion Date :
Jun 1, 2026
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Cocaine Use Disorder

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

Healthy Control

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Connecticut Mental Health Center New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04721418
Other Study ID Numbers:
  • 2000029552
First Posted:
Jan 22, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022