100 Participants NeededMy employer runs this trial

PET Imaging for Various Conditions

MG
AS
Overseen ByAlex Selloni, BA
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the role of cannabinoid receptors in the brain using PET imaging, a specialized brain scan. It focuses on healthy individuals and those with conditions such as cannabis use disorder, psychotic disorders, PTSD, and opioid use disorder. The study will capture brain images to examine the distribution of these receptors and potential differences across these groups. Suitable candidates include frequent cannabis users willing to abstain for four weeks, individuals diagnosed with PTSD or opioid use disorder, and those with a family history of alcoholism. The imaging will use [11-C]OMAR, a radioligand for visualizing cannabinoid receptors in PET scans.

As an unphased trial, this study offers participants the chance to contribute to foundational research that could lead to new insights and treatments.

Will I have to stop taking my current medications?

The trial does not clearly specify if you need to stop taking your current medications. However, some participants may be scanned both off and on medications to study their effects, so you might need to adjust your medication use during the trial.

What prior data suggests that this imaging method is safe for humans?

Research has shown that the radiotracer [11-C]OMAR, used in PET scans to examine cannabinoid receptors in the brain, is generally safe for people. In past studies, [11-C]OMAR did not cause major safety issues, even at high levels. Participants in clinical trials using this radiotracer have not experienced serious side effects. The safety of [11-C]OMAR makes it a suitable option for brain imaging studies focused on cannabinoid receptors.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses a novel technique to visualize cannabinoid receptors in the brain using Positron Emission Tomography (PET) scanning. Unlike traditional approaches, which often focus on treating symptoms, this method aims to provide a deeper understanding of how cannabinoid receptors are involved in various conditions like schizophrenia, PTSD, and opioid use disorder. This could lead to more targeted therapies in the future, as understanding receptor activity might unlock new ways to address these complex conditions. By seeing where and how these receptors are active, scientists hope to pave the way for innovative treatment strategies.

What evidence suggests that this trial's imaging technique could be effective for assessing cannabinoid receptors in various conditions?

Research has shown that certain parts of the brain, called cannabinoid receptors, are linked to mental health issues like schizophrenia and psychosis. Studies have found that regular cannabis use can increase the risk of developing schizophrenia. For individuals already at risk for psychotic disorders, cannabis use might worsen their condition. In this trial, participants from various groups, such as those with schizophrenia, cannabis dependence, and PTSD, will undergo imaging with [11-C]OMAR. This special imaging technique allows researchers to examine these receptors in the brain to better understand cannabis's effects. This could lead to new insights into how cannabis is involved in conditions like PTSD and opioid addiction.678910

Who Is on the Research Team?

DC

Deepak C D'Souza, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

Males ages 18-55
Willing to abstain from cannabis use for four weeks
Meets DSM-IV-TR criteria for schizophrenia or schizoaffective disorder
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo PET imaging to assess CB1 receptor availability using [11C]OMAR

4 weeks
3 visits (in-person) for cannabis use disorder arm; 1 visit (in-person) for other conditions

Follow-up

Participants are monitored for changes in receptor density and any adverse effects post-imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • [11-C]OMAR

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Group I: SchizophreniaExperimental Treatment1 Intervention
Group II: Prodrome for psychotic illnessExperimental Treatment1 Intervention
Group III: PTSD-Post Traumatic Stress DisorderExperimental Treatment1 Intervention
Group IV: Opioid Use DisorderExperimental Treatment1 Intervention
Group V: Healthy VolunteersExperimental Treatment1 Intervention
Group VI: Family history of alcoholismExperimental Treatment1 Intervention
Group VII: Cannabis dependenceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Cannabis use and the risk of developing a psychotic disorder

There is now reasonable evidence from longitudinal studies that regular cannabis use predicts an increased risk of schizophrenia and of reporting psychotic ...

Cannabis abuse and risk for psychosis in a prodromal ...

It is possible that cannabis use confers a greater risk for the later development of a psychotic illness in individuals who are already “at risk” for ...

Registered Ongoing Studies

The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) ...

Intensity of Psychoactive Substance Use Affects the ...

Intensity of psychoactive substance use correlated positively with the risk of appearance and intensity of prodromal symptoms of psychosis.

2025 RESIDENT & FELLOW RESEARCH DAY MAY 22, ...

... history of anxiety, depression, Post-traumatic stress disorder (PTSD), and OUD. He initially began using Percocet after a knee injury while ...

Quantification of cerebral cannabinoid receptors subtype 1 ...

Our new radioligand, [11C]OMAR ([11C]JHU75528 (Fan et al., 2006)), exhibited ... There were no significant safety issues with [11C] OMAR at high specific activity ...

Brain imaging of cannabinoid type I (CB1) receptors in ...

This PET imaging study found that 3-day abstinent females with cannabis use disorder (CUD) had, on average, 16-18% lower CB1 receptor ...

Test–retest reproducibility of cannabinoid-receptor type 1 ...

In vivo human brain CB1 availability has recently become quantifiable with PET and the use of tracers such as [18F]MK-9470 (Burns et al., 2007), [11C]OMAR (Wong ...

Age, gender and body-mass-index relationships with in- ...

The Radiotracer [(11)C]OMAR was developed for positron emission tomography (PET) imaging of cannabinoid type-1 receptors (CB1R). The objectives ...

Kinetic modeling of CB1 PET tracer [11C]OMAR in rhesus ...

Here we investigate quantification methods for [11C]OMAR in monkeys and humans. Methods Three rhesus monkeys underwent a total of 18 scans on the Focus220. Data ...