Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

NCT01730781 | Recruiting

• 3 other identifiers: 10050067351R21DA030702-01A11R21MH094961-01A1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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; Opioid-use Disorder; Post Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PET Imaging

  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.

  One time within 4 weeks of screening

Study Arms (7)

Schizophrenia

Patients diagnosed with schizophrenia both on medication and off medication

Radiation: [11-C]OMAR

Cannabis dependence

Frequent users of cannabis

Radiation: [11-C]OMAR

Family history of alcoholism

Healthy volunteers with a first degree relative with alcoholism

Radiation: [11-C]OMAR

Prodrome for psychotic illness

Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms

Radiation: [11-C]OMAR

Healthy Volunteers

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

Radiation: [11-C]OMAR

PTSD-Post Traumatic Stress Disorder

Patients diagnosed with Post Traumatic Stress Disorder

Radiation: [11-C]OMAR

Opioid Use Disorder

Patients diagnosed with Opioid Use Disorder

Radiation: [11-C]OMAR

Interventions

[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.

Cannabis dependence; Family history of alcoholism; Healthy Volunteers; Opioid Use Disorder; PTSD-Post Traumatic Stress Disorder; Prodrome for psychotic illness; Schizophrenia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population is composed of schizophrenia, cannabis dependence, prodromal for psychotic illness, family history of alcoholism, healthy volunteers, Post-Traumatic Stress Disorder and Opioid Use Disorder.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, 06519, United States

RECRUITING

Related Publications (1)

• Ranganathan M, Cortes-Briones J, Radhakrishnan R, Thurnauer H, Planeta B, Skosnik P, Gao H, Labaree D, Neumeister A, Pittman B, Surti T, Huang Y, Carson RE, D'Souza DC. Reduced Brain Cannabinoid Receptor Availability in Schizophrenia. Biol Psychiatry. 2016 Jun 15;79(12):997-1005. doi: 10.1016/j.biopsych.2015.08.021. Epub 2015 Aug 29.

  PMID: 26432420 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

At the screening visit, genomic DNA will be extracted from whole blood, assigned a code, and stored for analysis of group differences in the frequency of CB1R alleles and to examine the relationship between allelic variation at the CB1R locus and \[11-C\] OMAR binding. In addition, other genes or markers that may be related to brain function or to behavior may be studied.

MeSH Terms

Conditions

Schizophrenia; Marijuana Abuse; Opioid-Related Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Deepak C D'Souza, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Selloni, BA

CONTACT

203-974-7489; alexandria.selloni@yale.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: November 21, 2012
• Study Start: July 1, 2010
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)