Imaging Cannabinoid CB1 Receptors in Schizophrenia

NCT01063335 | Terminated

• 2 other identifiers: 10005810-M-0058
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

CB1 Receptor; Schizophrenia; Positron Emission Tomography (PET); Healthy Volunteers; HV

Outcome Measures

Primary Outcomes (1)

• Brain distribution volume of 18F-FMPEP-d2.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Schizophrenia:
• All subjects must be 18-55 years of age and be able to give written informed consent.
• All subjects must be healthy based on history and physical examination.
• Subjects must fulfill DSM-IV criteria (American Psychiatric Association 1987) for schizophrenia, schizophreniform disorder, or schizo-affective disorder.
• About half of the patients with schizophrenia will be carriers of the C allele of the rs2023239 SNP and half will not.
• Healthy Subjects:
• All subjects must be18-55 years of age and be able to give written informed consent.
• This comparison group must be healthy based on history and physical examination.
• About half of the healthy subjects will currently smoke cigarettes and about half will not. Smoking is defined by daily or near-daily smoking of more than 4 cigarettes/day, and non-smoking is defined by a life-time exposure of less than 100 cigarettes and none in the preceding 2 years.
• About half of the healthy subjects will be carriers of the C allele of the rs2023239 SNP and half will not.

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:

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Abi-Dargham A, Rodenhiser J, Printz D, Zea-Ponce Y, Gil R, Kegeles LS, Weiss R, Cooper TB, Mann JJ, Van Heertum RL, Gorman JM, Laruelle M. Increased baseline occupancy of D2 receptors by dopamine in schizophrenia. Proc Natl Acad Sci U S A. 2000 Jul 5;97(14):8104-9. doi: 10.1073/pnas.97.14.8104.

  PMID: 10884434 BACKGROUND

• Andreasson S, Allebeck P, Engstrom A, Rydberg U. Cannabis and schizophrenia. A longitudinal study of Swedish conscripts. Lancet. 1987 Dec 26;2(8574):1483-6. doi: 10.1016/s0140-6736(87)92620-1.

  PMID: 2892048 BACKGROUND

• Arseneault L, Cannon M, Poulton R, Murray R, Caspi A, Moffitt TE. Cannabis use in adolescence and risk for adult psychosis: longitudinal prospective study. BMJ. 2002 Nov 23;325(7374):1212-3. doi: 10.1136/bmj.325.7374.1212. No abstract available.

  PMID: 12446537 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Study Completion: September 20, 2012
• Last Updated: July 5, 2018

Record last verified: 2012-09-20

Locations

US (1)