Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT01730781
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • [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.

Study Details

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.

Key Dates

Start date
Jul 31, 2010
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Schizophrenia
    Patients diagnosed with schizophrenia both on medication and off medication
  • Arm: Cannabis dependence
    Frequent users of cannabis
  • Arm: Family history of alcoholism
    Healthy volunteers with a first degree relative with alcoholism
  • Arm: Prodrome for psychotic illness
    Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms
  • Arm: Healthy Volunteers
    Healthy volunteers with no current or past major medical or psychiatric history
  • Arm: PTSD-Post Traumatic Stress Disorder
    Patients diagnosed with Post Traumatic Stress Disorder
  • Arm: Opioid Use Disorder
    Patients diagnosed with Opioid Use Disorder

Primary Outcome Measure

PET Imaging [ Time Frame: One time within 4 weeks of screening ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health Center, Clinical Neuroscience Research UnitNew HavenConnecticut06519
Alex Selloni, BA
203-974-7489
Deepak C D'Souza, MD (PRINCIPAL_INVESTIGATOR)

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