Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Overseen By Alex Selloni, BA

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Neuro-psychiatric illness, Severe systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Deepak C D'Souza, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

Males ages 18-55

Willing to abstain from cannabis use for four weeks

Meets DSM-IV-TR criteria for schizophrenia or schizoaffective disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo PET imaging to assess CB1 receptor availability using [11C]OMAR

4 weeks

3 visits (in-person) for cannabis use disorder arm; 1 visit (in-person) for other conditions

Follow-up

Participants are monitored for changes in receptor density and any adverse effects post-imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [11-C]OMAR

How Is the Trial Designed?

Group I: Schizophrenia Experimental Treatment 1 Intervention

Patients diagnosed with schizophrenia both on medication and off medication

Group II: Prodrome for psychotic illness Experimental Treatment 1 Intervention

Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms

Group III: PTSD-Post Traumatic Stress Disorder Experimental Treatment 1 Intervention

Patients diagnosed with Post Traumatic Stress Disorder

Group IV: Opioid Use Disorder Experimental Treatment 1 Intervention

Patients diagnosed with Opioid Use Disorder

Group V: Healthy Volunteers Experimental Treatment 1 Intervention

Healthy volunteers with no current or past major medical or psychiatric history

Group VI: Family history of alcoholism Experimental Treatment 1 Intervention

Healthy volunteers with a first degree relative with alcoholism

Group VII: Cannabis dependence Experimental Treatment 1 Intervention

Frequent users of cannabis

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+