Imaging Study for Cocaine Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to examine synaptic density (connections between brain cells) in individuals with cocaine use disorder compared to those without it. The treatment involves 11C-UCB-J, a compound that visualizes these brain connections. Participants will be divided into two groups: those with cocaine use disorder and healthy individuals without the disorder. Individuals who have recently used cocaine and meet the criteria for cocaine use disorder may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance understanding and treatment of cocaine use disorder.
Will I have to stop taking my current medications?
The trial requires that participants do not use psychotropic or potentially psychoactive prescription medications. If you are currently taking these types of medications, you may need to stop before participating.
What prior data suggests that 11C-UCB-J is safe?
Research has shown that 11C-UCB-J is safe in human studies. It involves a PET scan to assess the brain's synaptic density. One study found that participants tolerated 11C-UCB-J well. The compound exits the body primarily through the kidneys and liver, with no major side effects, indicating good tolerance. While it aids in understanding brain changes in cocaine use disorder, evidence so far suggests it is safe for humans.12345
Why are researchers excited about this trial?
Most treatments for cocaine use disorder focus on managing cravings or withdrawal symptoms, often using behavioral therapies or medications like naltrexone and disulfiram. However, 11C-UCB-J stands out because it targets synaptic plasticity, a key process in the brain's response to cocaine. This approach allows researchers to explore how changes in synapse function might contribute to addiction. By using PET imaging with 11C-UCB-J, scientists can gain detailed insights into the brain's synaptic density, offering a novel perspective that could lead to more effective treatments for cocaine use disorder.
What evidence suggests that 11C-UCB-J is effective for measuring synaptic density in individuals with cocaine use disorder?
Research has shown that 11C-UCB-J, a special type of PET scan tracer, effectively measures the connections between brain cells in individuals with cocaine use disorder, one of the conditions studied in this trial. Studies have found that these individuals often have fewer connections in certain brain areas, indicating less connectivity among brain cells. Additionally, research has discovered that a single dose of cocaine can temporarily increase these connections. By using 11C-UCB-J, scientists in this trial aim to better understand how cocaine affects the brain over time, revealing changes in brain connections due to cocaine use.12467
Who Is on the Research Team?
Gustavo Angarita, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Treatment
Individuals with Cocaine Use Disorder (CUD) undergo one MRI and two 11C-UCB-J PET scans, along with neurocognitive tasks and sleep studies during a 3-week inpatient stay
Outpatient Follow-up
Cocaine users complete outpatient follow-ups twice a week to monitor synaptic density and sleep architecture
Healthy Control Assessment
Healthy controls undergo one MRI and one 11C-UCB-J PET scan, along with neurocognitive tasks as outpatients
What Are the Treatments Tested in This Trial?
Interventions
- 11C-UCB-J
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Lower Prefrontal Cortical Synaptic Vesicle Binding in ...
This article studied whether synaptic density is altered in cocaine use disorder with 11C-UCB-J positron emission tomography It showed altered (lower) synaptic ...
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A ...
The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls. Detailed ...
A single dose of cocaine raises SV2A density in ...
Cocaine provoked lasting changes of hippocampal synaptic SV2A density after a single exposure during adolescence.
Lower prefrontal cortical synaptic vesicle binding in ...
27,28. In vivo measures of 11C-UCB-J volume of distribution (VT) have been positively correlated with ex vivo measures of densities of both SV2A.
Lower prefrontal cortical synaptic vesicle binding in ...
found a negative correlation between [ 11 C]UCB-J binding and duration of cocaine abstinence, whereas years of lifetime use was unrelated to SV2A binding (47) .
Human biodistribution and dosimetry of [11C]-UCB-J, a PET ...
[11C]-UCB-J administration was safe and showed mixed renal and hepatobiliary clearance, with largest organ absorbed dose coefficients for the ...
Simplified Quantification of 11C-UCB-J PET Evaluated in a ...
This study includes a total of 141 subjects composed of 51 HSs (M/F=33/18,age:48±17,. BMI:27±5) and 90 NSs (M/F=59/31,age:42±15,BMI:28±5): 11 ...
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