Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET

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.

Inclusion Criteria:

1. 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.

2. Are between the ages of 18 and 65 years, inclusive.

3. 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)

4. Have arterial access sufficient to allow blood sampling as per the protocol.

5. Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures.

6. Have given written informed consent approved by the ethical review board governing
the site.

Exclusion Criteria:

1. 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.

2. Current substance abuse (other than AD) including marijuana use, or severe systemic
disease based on history and physical exam.

3. Laboratory tests with clinically significant abnormalities or positive urine
toxicology screen. (Note: specific laboratory tests are listed in section 3.4)

4. Prior participation in other research protocols in the last year such that radiation
exposure would exceed the annual limits.

5. Presence of ferromagnetic metal in the body or heart pacemaker.

6. Are persons who have previously completed or withdrawn from this study or any other
study investigating [C-11]OMAR.

7. Regularly use known drugs of abuse (other than alcohol) within 30 days of the study
and/or show positive findings on urinary drug screening.

8. Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV
antibodies.

9. Are women with a positive pregnancy test or women who are lactating.

10. 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

11. History of adverse drug reactions or intolerance to more than three types of
systemically administered medications

12. 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

13. 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

14. Have had exposure to ionizing radiation that in combination with the study tracer
would result in a cumulative exposure that exceeds recommended exposure limits