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NCT05683184 Clinical Trial

OMAR Opioid Use Disorder

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05683184
Other study ID # 2000033525
Secondary ID 1R21DA052864-01A
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 10, 2023
Est. completion date December 15, 2025

Study information
Verified date October 2023
Source Yale University
Contact Anahita Bassir Nia, MD
Phone 203-974-7540
Email anahita.bassirnia@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 15, 2025
Est. primary completion date December 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Connecticut Mental Health Center, Clinical Neuroscience Research Unit New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CB1R Availability To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls. One time within 4 weeks of screening
Secondary Serum Endocannabinoid Levels To explore group differences in serum endocannabinoid levels in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls. One time within 4 weeks of screening
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