Cocaine Use Disorder, Healthy Controls
Conditions
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.
Interventions
RADIATION11C-UCB-J
11C-UCB-J PET scan
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-group (CUD vs. HC) comparisons in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in mOFC. |
| Between-group (CUD vs. HC) comparisons in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC. |
| Between-group (CUD vs. HC) comparisons in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in vmPFC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Within subjects (CUD group) comparisons in mOFC. | Baseline versus 3 weeks after. | Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in mOFC. |
| 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 comparisons of volume of distribution (VT) in ACC. |
| Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of volume of distribution (VT) in vmPFC. |
| Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of volume of distribution (VT) in mOFC. |
| Between-group (CUD vs. HC) comparisons of binding potential in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of binding potential (BPND) in ACC. |
| Between-group (CUD vs. HC) comparisons of binding potential in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of binding potential (BPND) in mOFC. |
| Between-group (CUD vs. HC) comparisons of gray matter volume in ACC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of gray matter volume (GMV) in ACC. |
| Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of gray matter volume (GMV) in vmPFC. |
| Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of gray matter volume (GMV) in mOFC. |
| Between-group (CUD vs. HC) comparisons of binding potential in vmPFC. | CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient. | Between-group comparisons of binding potential (BPND) in vmPFC. |
| Within subjects (CUD group) comparisons in ACC. | Baseline versus 3 weeks after. | Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in ACC. |
| Within subjects (CUD group) comparisons in vmPFC. | Baseline versus 3 weeks after. | Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in vmPFC. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep studies | Baseline versus 3 weeks after. | Investigators will explore the association between synaptic density in the mPFC (measured by VT/fP, with 11C-UCB-J PET) and sleep architecture (measured by slow wave \[N3\] sleep and total sleep time \[TST\], using a sleep study device, e.g., polysomnography \[PSG\]), among subjects with CUD, within 1 week of abstinence and 3 weeks later. |
Countries
United States
Contacts
Primary ContactMarcella Mignosa, MD
Outcome results
None listed