OMAR Opioid Use Disorder

Study Overview
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Brief Summary
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The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) by measuring cannabinoid receptor 1 (CB1R) availability.

Detailed Description
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The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand [11C] OMAR, in healthy individuals and individuals diagnosed with opioid use disorder. Research participants may complete screening, MRI, PET scan and follow up visits.

Official Title
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Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder

Conditions
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Healthy Control, Opioid Use Disorder

Intervention / Treatment
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* Drug: [11C]OMAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent Male and female 18 years and older DSM-5 diagnosis of opioid use disorder (for OUD group) Physically healthy i.e., no clinically unstable medical conditions Written informed consent and have capacity to consent and comply with study procedures Exclusion Criteria: Current neuro-psychiatric illness or severe systemic disease (opioid use disorder is permitted in the OUD group). Presence of ferromagnetic metal in the body or heart pacemaker Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits Are claustrophobic

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>Healthy volunteers with no current or past major medical or psychiatric history | Drug: [11C]OMAR<br>* For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.<br>* Other names: [11C] JHU75528;|
| Other: Opioid Use Disorder<br>Patients diagnosed with opioid use disorder | Drug: [11C]OMAR<br>* For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.<br>* Other names: [11C] JHU75528;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CB1R Availability | To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls. | One time within 4 weeks of screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Endocannabinoid Levels | To explore group differences in serum endocannabinoid levels in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls. | One time within 4 weeks of screening |