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FAAH Availability in Psychiatric Disorders: A PET Study

FAAH Availability in Psychiatric Disorders: A PET Study

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04404712
Enrollment
6
Registered
2020-05-27
Start date
2020-09-23
Completion date
2021-06-30
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Post Traumatic Stress Disorder, Psychosis

Brief summary

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.

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.

Interventions

One PET scan involving administration of PET ligand \[11C\]MK-3168

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total distribution of [11C]MK-3168 in the brainPET scan dayFAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer \[11C\]MK-3168 total distribution

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026