Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-55
SponsorYale University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males ages 18-55

Willing to abstain from cannabis use for four weeks

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

Meets SIPS criteria for prodromal syndrome

Disqualifiers

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

Trial population

The study population is composed of schizophrenia, cannabis dependence, prodromal for psychotic illness, family history of alcoholism, healthy volunteers, Post-Traumatic Stress Disorder and Opioid Use Disorder.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • [11-C]OMAR

    Radiation

    The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Treatment groups

100 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Schizophrenia1 intervention
Group B: Cannabis dependence1 intervention
Group C: Family history of alcoholism1 intervention
Group D: Prodrome for psychotic illness1 intervention
Group E: Healthy Volunteers1 intervention
Group F: PTSD-Post Traumatic Stress Disorder1 intervention
Group G: Opioid Use Disorder1 intervention

Trial outcomes

Primary outcomes

1

PET Imaging

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.

Time frame
One time within 4 weeks of screening

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator