Actively Recruiting
Aberrant Synaptic Plasticity in Cocaine Use Disorder Using 11C-UCB-J PET Imaging
Led by Yale University · Updated on 2025-09-11
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying synaptic density in the brain by comparing individuals with cocaine use disorder (CUD) to healthy controls. This observational study aims to understand differences in brain function and structure related to cocaine use, using advanced imaging techniques. Participants include both healthy volunteers and those diagnosed with CUD, aged 21 to 60 years. Participants with CUD will stay as inpatients and undergo one MRI scan and two 11C-UCB-J PET scans, along with neurocognitive tasks. They will also complete sleep studies during their stay and attend outpatient follow-ups twice a week for up to nine weeks after discharge. Healthy controls will participate as outpatients, completing one MRI and one 11C-UCB-J PET scan and neurocognitive tasks. Throughout the study, researchers will assess brain regions including the anterior cingulate cortex, ventromedial prefrontal cortex, and medial orbitofrontal cortex. They will measure synaptic density, volume distribution, binding potential, and gray matter volume. Sleep studies and neurocognitive assessments will provide additional insights. Safety and health will be monitored with medical history, physical exams, and laboratory tests. The study is expected to continue until June 2026.
CONDITIONS
Brief Title
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 60 years
- Physically healthy based on medical history, physical, neurological, ECG, and laboratory exams
- Negative serum pregnancy test for females
- Diagnosed with Cocaine Use Disorder meeting DSM-5 criteria with recent positive urine test for cocaine use (for CUD group)
- Negative urine toxicology (for healthy control group)
You will not qualify if you...
- Diagnosis of other substance use disorders besides nicotine
- Major psychiatric disorders like schizophrenia, bipolar disorder, or major depression
- History of significant or uncontrolled medical or neurological illness
- Current use of psychotropic or potentially psychoactive prescription medications
- Any medical reason preventing safe MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants undergo MRI and 11C-UCB-J PET scans along with neurocognitive tasks to assess brain function.
1 to 2 visits depending on participant group
Duration - Approximately 3 weeks
Participants with Cocaine Use Disorder stay as inpatients and complete sleep studies during their stay.
Continuous inpatient stay with sleep studies on the first two and last two nights
Duration - Up to 9 weeks
Participants return for outpatient follow-ups to monitor progress after inpatient stay.
Twice weekly visits
Duration - Single timepoint at baseline
Healthy control participants are studied as outpatients with imaging and neurocognitive assessments.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
M
Marcella Mignosa, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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