Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
Location status: Recruiting
Location contact
Gustavo Angarita, MD
CONTACT
NCT Number: NCT04721418
The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.
Interested in participating?
Request Info21 year–60 year
All sexes
Observational
New Haven, Connecticut, 06519, United States
Location status: Recruiting
Gustavo Angarita, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
11C-UCB-J PET scan
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of volume of distribution (VT) in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of volume of distribution (VT) in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of volume of distribution (VT) in mOFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of binding potential (BPND) in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of binding potential (BPND) in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of binding potential (BPND) in mOFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of gray matter volume (GMV) in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of gray matter volume (GMV) in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of gray matter volume (GMV) in mOFC.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Yale University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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