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NCT Number: NCT05683184

OMAR 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.

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Key information

Conditions

Healthy Control Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, 06519, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]OMAR

Drug

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

Other names: [11C] JHU75528

Primary outcomes

  1. CB1R Availability

    Time frame: 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 outcomes

  1. Serum Endocannabinoid Levels

    Time frame: 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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2023
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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