FAAH Availability in Psychiatric Disorders: A PET Study

Alcohol Use Disorder Clinical Trial

Official title:

FAAH Availability in Psychiatric Disorders: A PET Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04404712
• Other study ID #: 2000027585
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 23, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Disease
• Mental Disorders
• Post Traumatic Stress Disorder
• Problem Behavior
• Psychosis
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• [11C]MK-3168
One PET scan involving administration of PET ligand [11C]MK-3168

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

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