FAAH Availability in Psychiatric Disorders: A PET Study

Early Phase 1

Terminated

• Conditions: Post Traumatic Stress Disorder; Alcohol Use Disorder; Psychosis
• Interventions: Drug: [11C]MK-3168

• Registration Number: NCT04404712
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-09-23
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[11C]MK-3168 PET Scan	[11C]MK-3168	-

Primary Outcome Measures

Name	Time	Method
Total distribution of [11C]MK-3168 in the brain	PET scan day	FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer \[11C\]MK-3168 total distribution

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States