Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-60
SponsorYale University
About this trial
The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
One group will have current Cocaine Use Disorder, the other group will be Healthy Controls
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
11C-UCB-J
Radiation11C-UCB-J PET scan
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Cocaine Use Disorder1 intervention
Group B: Healthy Control1 intervention
Trial outcomes
Primary outcomes
1
Between-group (CUD vs. HC) comparisons in ACC.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC.
Time frame
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.2
Between-group (CUD vs. HC) comparisons in vmPFC.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in vmPFC.
Time frame
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.3
Between-group (CUD vs. HC) comparisons in mOFC.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in mOFC.
Time frame
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.Secondary outcomes
1
Within subjects (CUD group) comparisons in ACC.
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.
Time frame
Baseline versus 3 weeks after.2
Within subjects (CUD group) comparisons in vmPFC.
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.
Time frame
Baseline versus 3 weeks after.3
Within subjects (CUD group) comparisons in mOFC.
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.
Time frame
Baseline versus 3 weeks after.4
Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.
Between-group comparisons of volume of distribution (VT) in ACC.
Time frame
CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.Other outcomes
1
Sleep studies
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.
Time frame
Baseline versus 3 weeks after.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov