OMAR Opioid Use Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Healthy Control
• Intervention / Treatment: Drug: [11C]OMAR

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Anahita Bassir Nia, MD; Phone Number: 203-974-7540; Email: anahita.bassirnia@yale.edu
• Study Contact Backup: Name: Angelina Contreras; Phone Number: 203-626-1105; Email: angelina.contreras@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Connecticut Mental Health Center, Clinical Neuroscience Research Unit
      • Contact: Angelina Contreras, BS; Phone Number: 203-626-1105; Email: angelina.contreras@yale.edu
      • Principal Investigator: Anahita Bassir Nia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

The study population is composed of opioid use disorder and healthy volunteers.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Anahita Bassir Nia, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; 4-cyano-1-(2,4-dichlorophenyl)-5-(4-methoxyphenyl)-N-(piperidin-1-yl)-1H-pyrazole-3-carboxamide
• Other Study ID Numbers: 2000033525; 1R21DA052864-01A1 (U.S. NIH Grant/Contract); 2K12DA000167-31 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No