OMAR Opioid Use Disorder

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05683184

Enrollment

Registered

2023-01-13

Start date

2023-03-10

Completion date

2027-12-15

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Control, Opioid Use Disorder

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.

Interventions

DRUG[11C]OMAR

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 * Hematocrit values lower than 30

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTAnahita Bassir Nia, MD

anahita.bassirnia@yale.edu203-974-7540

CONTACTAbby Dewey

abigail.dewey@yale.edu475-441-4190

PRINCIPAL_INVESTIGATORAnahita Bassir Nia, MD

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026