OMAR Opioid Use Disorder

Phase 1

Recruiting

• Conditions: Opioid Use Disorder; Healthy Control
• Interventions: Drug: [11C]OMAR

• Registration Number: NCT05683184
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-13
• Study Start: 2023-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	[11C]OMAR	Healthy volunteers with no current or past major medical or psychiatric history
Opioid Use Disorder	[11C]OMAR	Patients diagnosed with opioid use disorder

Primary Outcome Measures

Name	Time	Method
CB1R Availability	One time within 4 weeks of screening	To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Connecticut Mental Health Center, Clinical Neuroscience Research Unit; 🇺🇸 New Haven, Connecticut, United States