FAAH Availability in Psychiatric Disorders: A PET Study

NCT ID: NCT04404712

Last Updated: 2023-02-21

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Traumatic Stress Disorder Alcohol Use Disorder Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

[11C]MK-3168 PET Scan

Group Type EXPERIMENTAL

[11C]MK-3168

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[11C]MK-3168

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* Diagnosis of Post-Traumatic Stress Disorder


* Diagnosis of Alcohol Use Disorder


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohini Ranganathan

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohini Ranganathan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2000027585

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ketamine for Low Mood States in the ER
NCT01209845 COMPLETED PHASE1
THC Memory & Reward Learning Pilot
NCT05116527 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Cannabinoids, Learning, and Memory
NCT02407808 ACTIVE_NOT_RECRUITING PHASE1
CB1R in Synthetic Psychoactive Cannabinoids
NCT03539575 ACTIVE_NOT_RECRUITING NA
Endogenous Opioid Modulation by Ketamine
NCT03051945 WITHDRAWN PHASE3
MDMA for AUD/PTSD Comorbidity
NCT05943665 RECRUITING PHASE2
MDMA-Assisted Therapy for Pathological Narcissism
NCT06565494 RECRUITING EARLY_PHASE1