Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT01730781

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), National Institute of Mental Health (NIMH) (NIH)

100

Enrollment

Location

149

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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, 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	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Characterization of CB1 Receptors Using [11-C]OMAR

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

PET Imaging [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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