OMAR Opioid Use Disorder

NCT ID: NCT05683184

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2026-12-15

Brief Summary

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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

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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.

Conditions

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Healthy Control Opioid Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Healthy volunteers with no current or past major medical or psychiatric history

Group Type OTHER

[11C]OMAR

Intervention Type DRUG

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

Opioid Use Disorder

Patients diagnosed with opioid use disorder

Group Type OTHER

[11C]OMAR

Intervention Type DRUG

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

Interventions

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[11C]OMAR

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

Intervention Type DRUG

Other Intervention Names

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[11C] JHU75528

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Anahita Bassir Nia

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anahita Bassir Nia, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anahita Bassir Nia, MD

Role: CONTACT

Phone: 203-974-7540

Email: [email protected]

Angelina Contreras

Role: CONTACT

Phone: 203-626-1105

Email: [email protected]

Facility Contacts

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Angelina Contreras, BS

Role: primary

Other Identifiers

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2000033525

Identifier Type: -

Identifier Source: org_study_id

1R21DA052864-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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2K12DA000167-31

Identifier Type: NIH

Identifier Source: secondary_id

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