ClinicalTrials.gov
ClinicalTrials.gov Menu

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01730781
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : November 30, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Brief Summary:

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, using the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available.

Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.


Condition or disease Intervention/treatment
Schizophrenia Cannabis Dependence Prodromal for Psychotic Illness Family History of Alcoholism Radiation: [11-C]OMAR

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Other
Official Title: Characterization of CB1 Receptors Using [11-C]OMAR
Study Start Date : July 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Schizophrenia
Patients diagnosed with schizophrenia both on medication and off medication
Radiation: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
Cannabis dependence
Frequent users of cannabis
Radiation: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
Family history of alcoholism
Healthy volunteers with a first degree relative with alcoholism
Radiation: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
Prodrome for psychotic illness
Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms
Radiation: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
Healthy Volunteers
Healthy volunteers with no current or past major medical or psychiatric history
Radiation: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.



Primary Outcome Measures :
  1. PET Imaging [ Time Frame: One time within 4 weeks of screening ]

    This study will utilize the radioligand [11C]OMAR and High Resolution Research Tomography (HRRT) Positron Emission Tomography (PET) to measure brain CB1 receptor availability in all study populations.

    Those in the cannabis dependent population of the study will have PET scanning on three occasions: once within four weeks of screening while smoking as usual, once 48-hours later after remaining abstinent, and once four weeks later after remaining abstinent. The change in receptor density at each time point will be evaluated.

    Those in the other populations will have PET scanning done on one occasion within four weeks of screening.



Biospecimen Retention:   Samples With DNA
At the screening visit, genomic DNA will be extracted from whole blood, assigned a code, and stored for analysis of group differences in the frequency of CB1R alleles and to examine the relationship between allelic variation at the CB1R locus and [11-C] OMAR binding. In addition, other genes or markers that may be related to brain function or to behavior may be studied.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population is composed of schizophrenia, cannabis dependence, prodromal for psychotic illness, family history of alcoholism, and healthy volunteers.
Criteria

Inclusion Criteria:

  • Males ages 18-55
  • For cannabis users:
  • Willing to abstain from cannabis use for four weeks
  • For schizophrenia:
  • Meets DSM-IV-TR criteria for schizophrenia or schizoaffective disorder
  • For prodrome for psychotic illness:
  • Meets SIPS criteria for prodromal syndrome
  • For family history positive:
  • First degree relative with alcoholism

Exclusion Criteria:

  • Current neuro-psychiatric illness (including cannabis dependence) or severe systemic disease. Cannabis use disorder is permitted in the cannabis dependent group. Schizophrenia and schizoaffective disorder is permitted in the schizophrenia group. Psychotic symptoms are permitted in the prodromal group.
  • Presence of ferromagnetic metal in the body or heart pacemaker
  • Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits
  • Are claustrophobic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730781


Contacts
Contact: Gina Creatura, BA 203-974-7544 gina.creatura@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center, Clinical Neuroscience Research Unit Recruiting
New Haven, Connecticut, United States, 06519
Contact: Gina Creatura, BA    203-974-7544    gina.creatura@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Deepak C D'Souza, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01730781     History of Changes
Other Study ID Numbers: 1005006735
1R21DA030702-01A1 ( U.S. NIH Grant/Contract )
1R21MH094961-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by Deepak C. D'Souza, Yale University:
Cannabis dependence
Brain Imaging
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Marijuana Abuse
Alcoholism
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol-Related Disorders