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NCT03527485 · ClinicalTrials.gov registry record · NA
Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
A NA study of Cocaine Dependence and Opiate Dependence, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03527485: Completed NA study of Cocaine Dependence and Opiate Dependence, sponsored by Yale University.
NCT03527485 is a NA study of Cocaine Dependence and Opiate Dependence that has completed, run by Yale University. The registered enrollment target is 41 participants, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03527485, a NA study of Cocaine Dependence and Opiate Dependence, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to measure synaptic density in the brains (including in ventral striatum \[VS\] and medial prefrontal cortex \[mPFC\]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan. This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
Primary Outcome
PET scan- Participants underwent a single 11C-UCB-J PET scan to obtain measures of synaptic density (BPND). Structural magnetic resonance imaging (MRI) scans were also obtained for anatomical registration/partial volume correction (PVC) with the iterative Yang (IY) algorithm. BPND is a unitless metric. The study aimed to explore synaptic density differences in subjects with opioid use disorder compared to a control group within the sample.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 11UCB-J PET Scan
Study Locations (1)
Connecticut
- CT Mental Health Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2023-03-28 |
| Phase | NA |
What the finished NCT03527485 record still lists
NCT03527485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Cocaine Dependence appearing as the primary indexed condition, and to 1 intervention - of which 11UCB-J PET Scan is the first listed.
NCT03527485 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03527485 about?
NCT03527485 is a clinical study titled "Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET". This study aims to measure synaptic density in the brains (including in ventral striatum \[VS\] and medial prefrontal cortex \[mPFC\]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will un...
What is the current status of trial NCT03527485?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2019-01-01. Estimated completion is 2023-03-28.
What conditions does trial NCT03527485 study?
This clinical trial studies the following conditions: Cocaine Dependence, Opiate Dependence.
What interventions are being tested in trial NCT03527485?
The interventions under investigation include: 11UCB-J PET Scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03527485?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03527485 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03527485's enrollment target sits among peer trials
41 28th of 38 higher than 11 of 38 other Cocaine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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