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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence; Obesity; High Stress
• Intervention / Treatment: Drug: [C-11]OMAR

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alcohol; Subjects diagnosed with alcohol dependence	Drug: [C-11]OMAR; PET radioligand
Obese; Subjects diagnosed with obesity	Drug: [C-11]OMAR; PET radioligand
High Stress; Subjects diagnosed with high stress	Drug: [C-11]OMAR; PET radioligand
Healthy; Subjects deemed medically healthy	Drug: [C-11]OMAR; PET radioligand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No outcome measures for this study, this is an imaging study only	Upon study completion

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Marc N Potenza, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 0906005296