Imaging Cannabinoid CB1 Receptors in Schizophrenia

Stopped early

Conditions studied: Schizophrenia

In brief

Background: \- The CB1 receptor is a protein in the brain that is targeted by the active ingredients in cannabis (marijuana). Brain systems that react to cannabis may be involved in the causes and symptoms of schizophrenia and schizoaffective disorder. For instance, research studies have shown that the number of CB1 receptors may be different in people with schizophrenia, and there may be differences in the receptors themselves. Researchers are interested in using positron emission tomography (PET) to study CB1 receptors in people with and without schizophrenia, using a chemical tracer that attaches specifically to CB1 receptors. Objectives: \- To determine whether the CB1 receptor brain protein is different in people with and without schizophrenia. Eligibility: \- Individuals between 18 and 55 years of age who either have been diagnosed with schizophrenia/schizoaffective disorder or are healthy volunteers. Design: * Participants in the study must have previously enrolled in the National Institute of Mental Health protocol A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings (95-M-0150). * Participants will provide blood samples to test for the gene that contains information on the specific type of CB1 receptor each participant has. * Participants will have a PET scan and/or a magnetic resonance imaging (MRI) scan. * The PET scan will last approximately 2 hours. Participants will receive an injection of a small amount of chemical tracer to improve the quality of the images taken during the scan. * The MRI scan will last approximately 1 hour.

Key facts

Study ID

NCT01063335

Run by

National Institute of Mental Health (NIMH)

People needed

1

Starts

2010-02-01

Expected to finish

2012-09-20

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with Schizophrenia:
• Any serious medical condition as judged by the Principal Investigator.
• The patient has a guardian or a Durable Power of Attorney.
• Past or present diagnosis of primary mood disorders (such as bipolar illness or major depressive disorder). Any present substance abuse. Cannibis use within the last 2 months.
• Diagnosis of alcohol abuse or alcohol dependence as defined by DSM-IV (American Psychiatric Association 1987) criteria. Recent heavy use of alcohol. That is, subjects must have an alcohol audit score of less than or equal to 9. In addition, subjects must agree not to consume any alcohol in the three days prior to the PET scan.
• Positive test for HIV.
• Metallic foreign bodies that would be affected by the MRI scanner magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
• Head trauma resulting in a period of unconsciousness lasting longer than 1 hour.
• History of fetal alcohol syndrome or other neurodevelopmental disorder.
• History of seizures, other than in childhood and related to fever.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Positive urine drug screen.
• Pregnancy or breast feeding.
• Inability to lie flat on camera bed for about 2.5 h
• Healthy Subjects:
• Any current Axis I diagnosis; and any past or present substance abuse other than a total lifetime use of cannabis of less than 10 times and no cannabis use within the last 3 months.
• Family history of schizophrenia, schizophreniform disorder, or schizo-affective disorder.
• Clinically significant laboratory abnormalities.
• Recent heavy use of alcohol. That is, subjects must have an alcohol audit score of less than or equal to 9. In addition, subjects must agree not to consume any alcohol in the three days prior to the PET scan.
• Psychotropic medication use (including benzodiazepines and illicit drugs) during the 28 days (42 day for fluoxetine) prior to the PET scan.
• Serious medical problems.
• Positive test for HIV.
• Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
• Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
• History of fetal alcohol syndrome or other neurodevelopmental disorder.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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