Back to resultsOMAR Opioid Use Disorder
Primary Purpose
Healthy Control, Opioid Use Disorder
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]OMAR
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy Control
Eligibility Criteria
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
Sites / Locations
- Connecticut Mental Health Center, Clinical Neuroscience Research UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Healthy Volunteers
Opioid Use Disorder
Arm Description
Healthy volunteers with no current or past major medical or psychiatric history
Patients diagnosed with opioid use disorder
Outcomes
Primary Outcome Measures
CB1R Availability
To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05683184
First Posted
December 20, 2022
Last Updated
October 19, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05683184
Brief Title
OMAR Opioid Use Disorder
Official Title
Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Control, Opioid Use Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Healthy volunteers with no current or past major medical or psychiatric history
Arm Title
Opioid Use Disorder
Arm Type
Other
Arm Description
Patients diagnosed with opioid use disorder
Intervention Type
Drug
Intervention Name(s)
[11C]OMAR
Other Intervention Name(s)
[11C] JHU75528
Intervention Description
For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.
Primary Outcome Measure Information:
Title
CB1R Availability
Description
To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.
Time Frame
One time within 4 weeks of screening
Secondary Outcome Measure Information:
Title
Serum Endocannabinoid Levels
Description
To explore group differences in serum endocannabinoid levels in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.
Time Frame
One time within 4 weeks of screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anahita Bassir Nia, MD
Phone
203-974-7540
Email
anahita.bassirnia@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Contreras
Phone
203-626-1105
Email
angelina.contreras@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anahita Bassir Nia, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center, Clinical Neuroscience Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Contreras, BS
Phone
203-626-1105
Email
angelina.contreras@yale.edu
First Name & Middle Initial & Last Name & Degree
Anahita Bassir Nia, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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OMAR Opioid Use Disorder
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