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Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Characterization of CB1 Receptors Using [11-C]OMAR

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET brain scans and a tracer called OMAR to look at CB1 receptors, which respond to cannabis and are in everyone's brain. It is for men ages 18–55 who are healthy or have certain mental health conditions, drug use disorders, or a close family member with alcoholism.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men ages 18–55.
  • Cannabis use group: willing to stop using cannabis for four weeks.
  • Schizophrenia group: meet diagnosis rules for schizophrenia or schizoaffective disorder, which affect thoughts and may affect mood.
  • Early psychosis group: meet screening rules for early signs of an illness that affects what seems real.
  • Family history group: have a parent, sibling, or child with alcoholism.
  • PTSD group: meet diagnosis rules for post-traumatic stress disorder, a condition linked to a traumatic event.
  • Opioid use group: meet diagnosis rules for opioid use disorder.

Who can't join

  • A current brain or mental health illness, including cannabis dependence, unless it is a condition allowed in your study group.
  • A severe disease affecting the body.
  • Metal in the body that is attracted to magnets, or a heart pacemaker.
  • Past radiation exposure that, together with the study tracer, would go over recommended safety limits.
  • Fear of being in small, closed spaces.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CT