Official Title
Characterization of CB1 Receptors Using [11-C]OMAR
Brief Title
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Protocol ID
NCT01730781
Lead Sponsor
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, 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.
Enrollment Count
100 participants
Eligibility 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
- 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
Filters
Schizophrenia
Cannabis Dependence
Prodromal for Psychotic Illness
Family History of Alcoholism
Healthy Control
Opioid-use Disorder
Post Traumatic Stress Disorder
RECRUITING
ADULT