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Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD) | Clinical Trials | Clareo Health

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Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)

NCT02237703•NYU Langone Health

Summary

This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)\[11C\]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. age 18-55 years old
•2. currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50.
•1. age 18-55 years old
•2. no personal or first-degree family history of any Axis I diagnosis.

Exclusion Criteria

•1. any primary Axis I disorder other than PTSD (e.g. psychosis)
•2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
•3. a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence
•4. current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
•5. current breast feeding
•6. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests
•7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study
•9. Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects);
•10. use of opioid medications within 2 weeks of the PET study
•11. having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study
+14 more criteria

Locations (1)

NYU School of Medicine

New York, New York, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

March 1, 2015

Completion Date

August 1, 2016

Last Updated

January 20, 2017

Enrollment

ACTUAL participants

Conditions

Post-traumatic Stress Disorder (PTSD)Trauma

Interventions

Positron emission tomography (PET) imaging

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)

Inclusion Criteria

Exclusion Criteria

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