Imaging cannabinoid receptors in the brain using PET scans

Characterization of CB1 Receptors Using [11-C]OMAR

This study is trying to see how many cannabinoid receptors are in the brains of healthy people and those with conditions like cannabis use disorders or PTSD using special brain scans.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: Yale University (other)
• Drugs / interventions: radiation
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT01730781 on ClinicalTrials.gov

What this trial studies

This study aims to assess the availability of cannabinoid receptors (CB1R) in the human brain using Positron Emission Tomography (PET) imaging. It will involve healthy individuals and those with various conditions, including cannabis use disorders, schizophrenia, prodromal psychotic illness, family history of alcoholism, and PTSD. Participants will undergo PET scans with the radioligand OMAR to characterize the number and distribution of CB1R in these conditions. The study may expand its focus based on pilot data and emerging research on cannabinoid receptor function and psychiatric disorders.

Who should consider this trial

Good fit: Ideal candidates include males aged 18-55 with conditions such as cannabis use disorders, schizophrenia, prodromal psychotic illness, family history of alcoholism, PTSD, or opioid use disorder.

Not a fit: Patients with current neuro-psychiatric illnesses or severe systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cannabinoid receptors' role in various psychiatric conditions, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies have explored cannabinoid receptors in psychiatric conditions, suggesting potential for success, though this specific approach may be novel.

Eligibility criteria

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

Where this trial is running

New Haven, Connecticut

• Connecticut Mental Health Center, Clinical Neuroscience Research Unit — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Deepak C D'Souza, MD — Yale University
• Study coordinator: Alex Selloni, BA

Conditions: Schizophrenia, Cannabis Dependence, Prodromal for Psychotic Illness, Family History of Alcoholism, Healthy Control, Opioid-use Disorder, Post Traumatic Stress Disorder, Cannabis dependence