NCT04721418

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2021Jun 2026

First Submitted

Initial submission to the registry

January 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

January 14, 2021

Last Update Submit

September 9, 2025

Conditions

Cocaine Use DisorderHealthy Controls

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (12)

  • Within subjects (CUD group) comparisons in ACC.

    Baseline versus 3 weeks after.

  • Within subjects (CUD group) comparisons in vmPFC.

    Baseline versus 3 weeks after.

  • Within subjects (CUD group) comparisons in mOFC.

    Baseline versus 3 weeks after.

  • 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 (CUD vs. HC) of volume of distribution comparisons in vmPFC.

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

  • +7 more secondary outcomes

Other Outcomes (1)

  • Sleep studies

    Baseline versus 3 weeks after.

Study Arms (2)

Cocaine Use Disorder

Radiation: 11C-UCB-J

Healthy Control

Radiation: 11C-UCB-J

Interventions

11C-UCB-JRADIATION

11C-UCB-J PET scan

Cocaine Use DisorderHealthy Control

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

One group will have current Cocaine Use Disorder, the other group will be Healthy Controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Interventions

1-((3-(methylpyridin-4-yl)methyl)-4-(3,4,5-trifluorophenyl)pyrrolidin-2-one

Study Officials

  • Gustavo Angarita, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcella Mignosa, MD

CONTACT

203 974 7557marcella.mignosa@yale.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 22, 2021

Study Start

July 20, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

US(1)