OMAR Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [11C]OMAR.
- Who it may be relevant to
- Registry conditions: Healthy Control, Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
Overview
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.
Interventions
- Drug [11C]OMAR
For each \[11C\]OMAR PET scan, up to 20 mCi of \[11C\]OMAR will be administered.
Primary outcome measures
- CB1R Availability [Time frame: One time within 4 weeks of screening]
Secondary outcome measures (1)
- Serum Endocannabinoid Levels [Time frame: One time within 4 weeks of screening]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Connecticut Mental Health Center, Clinical Neuroscience Research Unit — New Haven
Identifiers
NCT: NCT05683184 · 2000033525 · 1R21DA052864-01A1 · 2K12DA000167-31