Clinical trial NCT04721418: Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Official title: Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cocaine Use Disorder
Healthy Controls
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: One group will have current Cocaine Use Disorder, the other group will be Healthy Controls

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.

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

Primary outcomes:
measure: Between-group (CUD vs. HC) comparisons in ACC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons in vmPFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons in mOFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Secondary outcomes:
measure: Within subjects (CUD group) comparisons in ACC.
timeFrame: Baseline versus 3 weeks after.
measure: Within subjects (CUD group) comparisons in vmPFC.
timeFrame: Baseline versus 3 weeks after.
measure: Within subjects (CUD group) comparisons in mOFC.
timeFrame: Baseline versus 3 weeks after.
measure: Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons of binding potential in ACC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons of binding potential in vmPFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons of binding potential in mOFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons of gray matter volume in ACC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
measure: Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC.
timeFrame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Other outcomes:
measure: Sleep studies
timeFrame: Baseline versus 3 weeks after.
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Gustavo Angarita, MD
role: PRINCIPAL_INVESTIGATOR
References: