OMAR Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683184
• Other study ID #: 2000033525
• Secondary ID: 1R21DA052864-01A
• Status: Recruiting
• Phase: Phase 1
• Start date: March 10, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Anahita Bassir Nia, MD
• Phone: 203-974-7540
• Email: anahita.bassirnia[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Control
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• [11C]OMAR
For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center, Clinical Neuroscience Research Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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