OMAR Opioid Use Disorder

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05683184
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
30
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Dec 15, 2025
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Healthy Volunteers

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

Drug: [11C]OMAR
For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.
Other Names:
  • [11C] JHU75528
  • Opioid Use Disorder

    Patients diagnosed with opioid use disorder

    Drug: [11C]OMAR
    For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.
    Other Names:
  • [11C] JHU75528
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Able to provide informed consent

    • Male and female 18-55 years old (inclusive)

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yale University
    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anahita Bassir Nia, Assistant Professor of Psychiatry, Yale University
    ClinicalTrials.gov Identifier:
    NCT05683184
    Other Study ID Numbers:
    • 2000033525
    First Posted:
    Jan 13, 2023
    Last Update Posted:
    Jan 13, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2023