Measuring brain changes in cocaine use disorder
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Yale University · NCT04721418
This study is testing how cocaine use affects brain structure by comparing the brain scans of people with cocaine use disorder to those of healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04721418 on ClinicalTrials.gov |
What this trial studies
This research aims to compare synaptic density in the brains of individuals with cocaine use disorder to that of healthy controls using advanced imaging techniques. Participants will undergo MRI and 11C-UCB-J PET scans, alongside neurocognitive assessments. Healthy controls will be studied as outpatients, while individuals with cocaine use disorder will be admitted as inpatients for comprehensive evaluations, including sleep studies. Follow-up assessments will occur twice a week for up to nine weeks post-discharge for cocaine users.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21-60 with a diagnosis of cocaine use disorder or healthy individuals without substance use disorders.
Not a fit: Patients with other substance use disorders or significant psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the neurobiological changes associated with cocaine use disorder, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have shown promise in using neuroimaging to understand substance use disorders, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Connecticut Mental Health Center — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Gustavo Angarita, MD — Yale University
- Study coordinator: Marcella Mignosa, MD
- Email: marcella.mignosa@yale.edu
- Phone: 203 974 7557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cocaine Use Disorder, Healthy Controls