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 7, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder 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 Healthy Control Opioid-use Disorder Post Traumatic Stress Disorder | 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 2024 |
Estimated Study Completion Date : | December 2024 |
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. |
PTSD-Post Traumatic Stress Disorder
Patients diagnosed with Post Traumatic Stress Disorder
|
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. |
Opioid Use Disorder
Patients diagnosed with Opioid Use Disorder
|
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. |
- 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
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 |
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
- For Post-Traumatic Stress Disorder
- Meets DSM-IV-TR criteria for PTSD
- For OUD
- Meets DSM-IV-TR criteria for Opioid Use Disorder
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. Post-Traumatic Stress Disorder is permitted in the PTSD group and Opioid Use Disorder is permitted in the OUD 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
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
Contact: Alex Selloni, BA | 203-974-7489 | alexandria.selloni@yale.edu |
United States, Connecticut | |
Connecticut Mental Health Center, Clinical Neuroscience Research Unit | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Alex Selloni, BA 203-974-7489 alexandria.selloni@yale.edu | |
Principal Investigator: Deepak C D'Souza, MD |
Principal Investigator: | Deepak C D'Souza, MD | Yale University |
Responsible Party: | Deepak C. D'Souza, Associate Professor, Yale University |
ClinicalTrials.gov Identifier: | NCT01730781 |
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 7, 2023 |
Last Verified: | November 2023 |
Cannabis dependence Brain Imaging Schizophrenia |
Control PTSD OUD |
Marijuana Abuse Opioid-Related Disorders Alcoholism Schizophrenia Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Schizophrenia Spectrum and Other Psychotic Disorders |
Mental Disorders Trauma and Stressor Related Disorders Substance-Related Disorders Chemically-Induced Disorders Narcotic-Related Disorders Alcohol-Related Disorders |