Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01730781

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Schizophrenia Cannabis Dependence Chemically-Induced Disorders Family History of Alcoholism Healthy Control Marijuana Abuse Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Post Traumatic Stress Disorder Prodromal for Psychotic Illness Schizophrenia Spectrum and Other Psychotic Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Alex Selloni, BA

CONTACT

[email protected]

203-974-7489

Deepak C D'Souza, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[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.

Primary outcomes

  1. PET Imaging

    Time frame: One time within 4 weeks of screening

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Selloni, BA

CONTACT

[email protected]

203-974-7489

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Characterization of CB1 Receptors Using [11-C]OMAR

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2012
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.