Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- CB1R Availability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy Volunteers
Healthy volunteers with no current or past major medical or psychiatric history
Intervention: [11C]OMAR (Drug)
Opioid Use Disorder
Patients diagnosed with opioid use disorder
Intervention: [11C]OMAR (Drug)
Outcomes
Primary Outcomes
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
- Serum Endocannabinoid Levels(One time within 4 weeks of screening)
Investigators
Anahita Bassir Nia
Assistant Professor of Psychiatry
Yale University