Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

NCT ID: NCT01730781

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Schizophrenia

Patients diagnosed with schizophrenia both on medication and off medication

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Cannabis dependence

Frequent users of cannabis

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Family history of alcoholism

Healthy volunteers with a first degree relative with alcoholism

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Prodrome for psychotic illness

Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Healthy Volunteers

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

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

PTSD-Post Traumatic Stress Disorder

Patients diagnosed with Post Traumatic Stress Disorder

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Opioid Use Disorder

Patients diagnosed with Opioid Use Disorder

[11-C]OMAR

Intervention Type RADIATION

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Interventions

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[11-C]OMAR

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak C D'Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alex Selloni, BA

Role: CONTACT

203-974-7489

Facility Contacts

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Alex Selloni, BA

Role: primary

203-974-7489

References

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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.

Reference Type DERIVED
PMID: 26432420 (View on PubMed)

Other Identifiers

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1R21DA030702-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R21MH094961-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1005006735

Identifier Type: -

Identifier Source: org_study_id

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