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Search / Trial NCT01063335

Imaging Cannabinoid CB1 Receptors in Schizophrenia

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Feb 4, 2010

Trial Information

Current as of July 22, 2025

Terminated

Keywords

Cb1 Receptor Schizophrenia Positron Emission Tomography (Pet) Healthy Volunteers Hv

ClinConnect Summary

Schizophrenia is a debilitating mental disorder with a complex and multifactorial etiology. The exact pathophysiological mechanisms have remained elusive, but a large body of evidence points toward abnormalities in a number of brain neurotransmitter systems: dopamine, glutamate, and gamma-amino butyric acid (GABA). Pharmacological studies have shown that acute exposure to cannabis is able to induce psychotic symptoms in healthy individuals and exacerbate symptoms in patients with an established psychotic illness. In addition, epidemiological studies have established that cannabis use in ear...

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • Patients with Schizophrenia:
  • 1. All subjects must be 18-55 years of age and be able to give written informed consent.
  • 2. All subjects must be healthy based on history and physical examination.
  • 3. Subjects must fulfill DSM-IV criteria (American Psychiatric Association 1987) for schizophrenia, schizophreniform disorder, or schizo-affective disorder.
  • 4. About half of the patients with schizophrenia will be carriers of the C allele of the rs2023239 SNP and half will not.
  • Healthy Subjects:
  • 1. All subjects must be18-55 years of age and be able to give written informed consent.
  • 2. This comparison group must be healthy based on history and physical examination.
  • 3. 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.
  • 4. About half of the healthy subjects will be carriers of the C allele of the rs2023239 SNP and half will not.
  • EXCLUSION CRITERIA:
  • Patients with Schizophrenia:
  • 1. Any serious medical condition as judged by the Principal Investigator.
  • 2. The patient has a guardian or a Durable Power of Attorney.
  • 3. 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.
  • 4. 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.
  • 5. Positive test for HIV.
  • 6. 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.
  • 7. Head trauma resulting in a period of unconsciousness lasting longer than 1 hour.
  • 8. History of fetal alcohol syndrome or other neurodevelopmental disorder.
  • 9. History of seizures, other than in childhood and related to fever.
  • 10. Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
  • 11. Positive urine drug screen.
  • 12. Pregnancy or breast feeding.
  • 13. Inability to lie flat on camera bed for about 2.5 h
  • Healthy Subjects:
  • 1. 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.
  • 2. Family history of schizophrenia, schizophreniform disorder, or schizo-affective disorder.
  • 3. Clinically significant laboratory abnormalities.
  • 4. 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.
  • 5. Psychotropic medication use (including benzodiazepines and illicit drugs) during the 28 days (42 day for fluoxetine) prior to the PET scan.
  • 6. Serious medical problems.
  • 7. Positive test for HIV.
  • 8. 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.
  • 9. Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
  • 10. History of fetal alcohol syndrome or other neurodevelopmental disorder.
  • 11. History of seizures, other than in childhood and related to fever.
  • 12. Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
  • 13. Positive urine drug screen.
  • 14. Pregnancy or breast feeding.
  • 15. Inability to lie flat on camera bed for about 2.5 h

About National Institute Of Mental Health (Nimh)

The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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