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

NCT ID: NCT04721418

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Cocaine Use Disorder; Healthy Controls

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cocaine Use Disorder

11C-UCB-J

Intervention Type: RADIATION

11C-UCB-J PET scan

Healthy Control

11C-UCB-J

Intervention Type: RADIATION

11C-UCB-J PET scan

Interventions

11C-UCB-J

11C-UCB-J PET scan

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Angarita, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marcella Mignosa, MD

Role: CONTACT

marcella.mignosa@yale.edu

203 974 7557

Facility Contacts

Gustavo Angarita, MD

Role: primary

Other Identifiers

1R01DA052454-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000029552

Identifier Type: -

Identifier Source: org_study_id