OMAR Opioid Use Disorder

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Healthy Control; Opioid Use Disorder

Treatments: Drug: [11C]OMAR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05683184

2000033525

1R21DA052864-01A1 (U.S. NIH Grant/Contract)

2K12DA000167-31 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Healthy Volunteers

Other group

Description:

Healthy volunteers with no current or past major medical or psychiatric history

Treatment:

Drug: [11C]OMAR

Opioid Use Disorder

Other group

Description:

Patients diagnosed with opioid use disorder

Treatment:

Drug: [11C]OMAR