Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID05683184

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

Led by Yale University · Updated on 2026-04-28

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how the endocannabinoid system functions in people with opioid use disorder (OUD) by measuring the availability of cannabinoid receptor 1 (CB1R) in the brain. This research aims to better understand differences between individuals with OUD and healthy volunteers using advanced brain imaging techniques. The study is a phase 1, interventional trial led by Yale University focusing on brain receptor imaging using a specialized radioligand. Participants will undergo Positron Emission Tomography (PET) scans using a drug called [11C]OMAR to visualize CB1 receptors. Up to 20 mCi of [11C]OMAR will be administered during each PET scan. Study groups include healthy volunteers without significant medical or psychiatric history and individuals diagnosed with opioid use disorder. The study involves screening, MRI, PET scans, and follow-up visits. During the study, participants will have brain imaging and blood tests to assess CB1 receptor availability and serum endocannabinoid levels within four weeks of screening. Researchers will monitor these outcomes to compare between groups. The trial includes no randomization or blinding, and participants will be followed for the duration necessary to complete imaging and assessments. The study is expected to complete by December 2026.

CONDITIONS

Brief Title

OMAR Opioid Use Disorder

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • Male and female 18 years and older
  • DSM-5 diagnosis of opioid use disorder (for OUD group)
  • Physically healthy with no clinically unstable medical conditions
  • Written informed consent and capacity to comply with study procedures
Not Eligible

You will not qualify if you...

  • Current neuro-psychiatric illness or severe systemic disease (except opioid use disorder in OUD group)
  • Presence of ferromagnetic metal in the body or heart pacemaker
  • Prior exposure to ionizing radiation exceeding recommended limits when combined with study tracer
  • Claustrophobia

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 4 weeks of screening

Participants undergo brain imaging using Positron Emission Tomography (PET) with the radioligand [11C]OMAR to characterize cannabinoid receptors.

1 imaging visit (in-person)

Follow-up

Duration - Duration not specified

Participants may complete follow-up visits to monitor outcomes after imaging.

Follow-up visit(s) as needed

Trial Site Locations

Total: 1 location

1

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

A

Anahita Bassir Nia, MD

A

Angelina Contreras

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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