Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET

Study Overview
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Brief Summary
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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.

Official Title
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Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET

Conditions
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Opiate Dependence, Cocaine Dependence

Intervention / Treatment
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* Diagnostic Test: 11UCB-J PET Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-55 years; Voluntary, written, informed consent; Physically healthy by medical history, physical, neurological, ECG and laboratory examinations; DSM-5 criteria for Cocaine Use Disorder or Opiate Use Disorder; Documented evidence (by urine toxicology) of 2 weeks abstinence from cocaine and 4 weeks abstinence from opiates; For females, a negative serum pregnancy (HCG) test; Full scale and verbal IQs > 80 (Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)). Exclusion Criteria: A history of other substance dependence (e.g., alcohol, 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 uncontrolled medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizures, traumatic brain injury) illness; A history of seizures; Current use of psychotropic and/or potentially psychoactive prescription medications; Medical contraindications to participation in a magnetic resonance (MR) imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.) as recorded on the MR safety sheet; For females, physical or laboratory (HCG) evidence of pregnancy; PTT and PT/INR lab results not appropriate for arterial line placement; Taking anticoagulants; Being prescribed methadone/buprenorphine upon screening.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Opiate Use Disorder (OUD)<br>30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan. | Diagnostic Test: 11UCB-J PET Scan<br>* 11UCB-J PET Scan<br>|
| Other: Cocaine Use Disorder (CUD)<br>30 subjects meeting cocaine dependence criteria 11UCB-J PET Scan. | Diagnostic Test: 11UCB-J PET Scan<br>* 11UCB-J PET Scan<br>|
| Other: Healthy Controls (HC)<br>30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan. | Diagnostic Test: 11UCB-J PET Scan<br>* 11UCB-J PET Scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11C-UCB-J PET synaptic density | PET scan | 90 minute scan |