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

NCT ID: NCT01719497

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-05-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Alcohol

Subjects diagnosed with alcohol dependence

[C-11]OMAR

Intervention Type: DRUG

PET radioligand

Obese

Subjects diagnosed with obesity

[C-11]OMAR

Intervention Type: DRUG

PET radioligand

High Stress

Subjects diagnosed with high stress

[C-11]OMAR

Intervention Type: DRUG

PET radioligand

Healthy

Subjects deemed medically healthy

[C-11]OMAR

Intervention Type: DRUG

PET radioligand

Interventions

[C-11]OMAR

PET radioligand

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc N Potenza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0906005296

Identifier Type: -

Identifier Source: org_study_id