Healthy ControlPhase 1NCT05683184
OMAR Opioid Use Disorder
A Phase 1 study testing [11C]OMAR in people with Healthy Control and Opioid Use Disorder, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Control, Opioid Use Disorder
- What is being tested?
- [11C]OMAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 15 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Mental Health Center, Clinical Neuroscience Research Unit
New Haven, Connecticut, 06519
Abby Dewey, 475-441-4190, abigail.dewey@yale.edu
Anahita Bassir Nia, MD
About this study
Official title: Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
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.
Read the 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.
- Conditions
- Healthy Control, Opioid Use Disorder
- Being tested
- [11C]OMAR
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]OMARDrug
Also called [11C] JHU75528
For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Healthy volunteers with no current or past major medical or psychiatric history Receives: Drug: [11C]OMAR |
| Opioid Use Disorder | Other | Patients diagnosed with opioid use disorder Receives: Drug: [11C]OMAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CB1R Availability
To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.
Measured: One time within 4 weeks of screening
Secondary outcomes (1)
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.
Measured: One time within 4 weeks of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start10 Mar 2023
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Anahita Bassir Nia, Yale University
- Investigators
- Anahita Bassir Nia, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683184
- Sponsor's protocol ID
- 2000033525
- Other IDs
- 1R21DA052864-01A1, 2K12DA000167-31
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05683184
- Acronym / sponsor ID
- 2000033525
- Conditions
- Healthy Control, Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Drug: [11C]OMARHealthy volunteers with no current or past major medical or psychiatric history |
| Opioid Use Disorder | Other | Drug: [11C]OMARPatients diagnosed with opioid use disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]OMARAlso: [11C] JHU75528For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered. | Drug | Healthy Volunteers, Opioid Use Disorder |
Primary outcome
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.
1 secondary outcome
Serum Endocannabinoid Levels
Time frame: One time within 4 weeks of screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anahita Bassir Nia, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [11C]OMAR in people with Healthy Control and Opioid Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anahita Bassir Nia, MD (203-974-7540, anahita.bassirnia@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CB1R Availability (time frame: One time within 4 weeks of screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.