ObesityNCT01719497
Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET
An observational study of Obesity and Alcohol Dependence, run by Yale University at 1 site in United States.
Trial summary
The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and binding characteristics. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Alcohol Dependence, High Stress
- What is being tested?
- [C-11]OMAR
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: N = 30 Medically Healthy control subjects N = 30 Subjects with high stress exposure N = 30 Subjects with Alcohol Dependence (AD) N = 30 Obese subjects
Who may be able to join
- Are overtly healthy males or females (other than AD or obesity), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
- Are between the ages of 18 and 65 years, inclusive.
- Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. (Note: specific laboratory tests are listed in section 3.4)
- Have arterial access sufficient to allow blood sampling as per the protocol.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have given written informed consent approved by the ethical review board governing the site.
Who cannot join
- Are currently enrolled in, or discontinued within the last [30 days] from, a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Current substance abuse (other than AD) including marijuana use, or severe systemic disease based on history and physical exam.
- Laboratory tests with clinically significant abnormalities or positive urine toxicology screen. (Note: specific laboratory tests are listed in section 3.4)
- Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
- Presence of ferromagnetic metal in the body or heart pacemaker.
- Are persons who have previously completed or withdrawn from this study or any other study investigating [C-11]OMAR.
Show all 14Show fewer
- Regularly use known drugs of abuse (other than alcohol) within 30 days of the study and/or show positive findings on urinary drug screening.
- Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
- Are women with a positive pregnancy test or women who are lactating.
- Have a history of head trauma with prolonged loss of consciousness (>10 minutes), or any neurological condition including stroke or seizure (excluding a single childhood febrile seizure) or a history of migraine headaches
- History of adverse drug reactions or intolerance to more than three types of systemically administered medications
- Have used any prescription medication (except for oral contraceptives or hormone replacement therapy) or over-the-counter medication (including herbal remedies or diet aids) within 14 days of the imaging session. Multiple vitamins are specifically permitted
- Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
- Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and binding characteristics.
Read the detailed description
This is a pilot, 2-part study to assess the kinetics of radioactivity in medically healthy subjects, subjects with alcohol dependency (AD), and obese subjects following the intravenous administration of the imaging agent [C-11]OMAR.
- Conditions
- Obesity, Alcohol Dependence, High Stress
- Being tested
- [C-11]OMAR
- Medical subject headings
- Obesity, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[C-11]OMARDrug
PET radioligand
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Subjects diagnosed with alcohol dependence Receives: Drug: [C-11]OMAR | |
| Obese | Subjects diagnosed with obesity Receives: Drug: [C-11]OMAR | |
| High Stress | Subjects diagnosed with high stress Receives: Drug: [C-11]OMAR | |
| Healthy | Subjects deemed medically healthy Receives: Drug: [C-11]OMAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
No outcome measures for this study, this is an imaging study only
Measured: Upon study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc N Potenza, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719497
- Sponsor's protocol ID
- 0906005296
- Status last verified
- Jul 2022
- First submitted
- 29 Oct 2012
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET
- ClinicalTrials.gov ID
- NCT01719497
- Acronym / sponsor ID
- 0906005296
- Conditions
- Obesity, Alcohol Dependence, High Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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 aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and binding characteristics.
Detailed description
This is a pilot, 2-part study to assess the kinetics of radioactivity in medically healthy subjects, subjects with alcohol dependency (AD), and obese subjects following the intravenous administration of the imaging agent [C-11]OMAR.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol | – | Drug: [C-11]OMARSubjects diagnosed with alcohol dependence |
| Obese | – | Drug: [C-11]OMARSubjects diagnosed with obesity |
| High Stress | – | Drug: [C-11]OMARSubjects diagnosed with high stress |
| Healthy | – | Drug: [C-11]OMARSubjects deemed medically healthy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- N = 30 Medically Healthy control subjects N = 30 Subjects with high stress exposure N = 30 Subjects with Alcohol Dependence (AD) N = 30 Obese subjects
Key inclusion criteria (6 listed)
- Are overtly healthy males or females (other than AD or obesity), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
- Are between the ages of 18 and 65 years, inclusive.
- Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. (Note: specific laboratory tests are listed in section 3.4)
- Have arterial access sufficient to allow blood sampling as per the protocol.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Key exclusion criteria (14 listed)
- Are currently enrolled in, or discontinued within the last [30 days] from, a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Current substance abuse (other than AD) including marijuana use, or severe systemic disease based on history and physical exam.
- Laboratory tests with clinically significant abnormalities or positive urine toxicology screen. (Note: specific laboratory tests are listed in section 3.4)
- Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
- Presence of ferromagnetic metal in the body or heart pacemaker.
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 |
|---|---|---|
| [C-11]OMARPET radioligand | Drug | Alcohol, Healthy, High Stress, Obese |
Primary outcome
No outcome measures for this study, this is an imaging study only
Time frame: Upon study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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. This study is not recruiting at the moment.
Marc N Potenza, MD, PhD 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?
An observational study of Obesity and Alcohol Dependence, 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 13 Jul 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No outcome measures for this study, this is an imaging study only (time frame: Upon study completion). 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 13 Jul 2022.