NCT04404712

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

May 22, 2020

Last Update Submit

February 16, 2023

Conditions

Post Traumatic Stress DisorderAlcohol Use DisorderPsychosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

[11C]MK-3168 PET Scan

EXPERIMENTAL
Drug: [11C]MK-3168

Interventions

[11C]MK-3168DRUG

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

[11C]MK-3168 PET Scan

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcoholismPsychotic Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Mohini Ranganathan, MBBS

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 27, 2020

Study Start

September 23, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

US(1)