Recruiting

Cannabinoid Receptors

Sponsor:

Yale University

Code:

NCT01730781

Conditions

Schizophrenia

Cannabis Dependence

Prodromal for Psychotic Illness

Family History of Alcoholism

Healthy Control

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

[11-C]OMAR

Study Details

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.

Conditions

Schizophrenia

Cannabis Dependence

Prodromal for Psychotic Illness

Family History of Alcoholism

Healthy Control

Study ID

NCT01730781

Start date

Jul, 2010

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Schizophrenia

Patients diagnosed with schizophrenia both on medication and off medication

Cannabis dependence

Frequent users of cannabis

Family history of alcoholism

Healthy volunteers with a first degree relative with alcoholism

Prodrome for psychotic illness

Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms

Healthy Volunteers

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

PTSD-Post Traumatic Stress Disorder

Patients diagnosed with Post Traumatic Stress Disorder

Opioid Use Disorder

Patients diagnosed with Opioid Use Disorder

Interventions

[11-C]OMAR

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Principal Investigator:

Deepak C D'Souza, MD

More Information

Sponsor

Yale University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • Cannabis dependence
  • Brain Imaging
  • Schizophrenia
  • Control
  • PTSD
  • OUD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-04-27.