FAAH Availability in Psychiatric Disorders: A PET Study

February 16, 2023 updated by: Mohini Ranganathan, Yale University
The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy control individuals.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 18 and 65 years, inclusive
  • Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs

PTSD Inclusion Criteria:

  • Diagnosis of Post-Traumatic Stress Disorder

AUD Inclusion Criteria:

  • Diagnosis of Alcohol Use Disorder

Psychosis Inclusion Criteria:

  • Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder

Exclusion Criteria:

  • Presence of ferromagnetic metal in the body or heart pacemaker
  • Women with a positive pregnancy test or women who are lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [11C]MK-3168 PET Scan
Drug: [11C]MK-3168
One PET scan involving administration of PET ligand [11C]MK-3168

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total distribution of [11C]MK-3168 in the brain
Time Frame: PET scan day
FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution
PET scan day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027585

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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