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

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.

Study Overview

• Status: Terminated
• Conditions: Trauma; Post-traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Other: Positron emission tomography (PET) imaging

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects are between the age range of 18 to 55, are medically healthy and currently not taking any medications to treat any medical illness, have a history of post-traumatic stress disorder, or are a healthy control who has or has not been exposed to trauma.

Description

Inclusion criteria for patients with PTSD:

1. age 18-55 years old
2. currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50.

Exclusion criteria for patients with PTSD:

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
8. general MRI exclusion criteria, i.e. pacemakers, metals in the body
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
12. seriously claustrophobic
13. blood donation within 8 weeks prior to the study.

Inclusion criteria for Healthy Subjects:

1. age 18-55 years old
2. no personal or first-degree family history of any Axis I diagnosis.

Exclusion criteria for Healthy Subjects:

1. any history or current primary Axis I disorder
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 (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
8. general MRI exclusion criteria, i.e. pacemakers, metals in the body
9. 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 ECG that, in the opinion of the investigator, increases the risks associated with participation in the study
12. seriously claustrophobic
13. blood donation within 8 weeks prior to the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-traumatic stress disorder (PTSD)	Other: Positron emission tomography (PET) imaging; Positron emission tomography (PET) imaging
Trauma Control (TC)	Other: Positron emission tomography (PET) imaging; Positron emission tomography (PET) imaging
Healthy Control (HC)	Other: Positron emission tomography (PET) imaging; Positron emission tomography (PET) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET	To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET. Hypothesis: PTSD will show greater [11C]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.	Two months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Yale University
• Investigators: Principal Investigator: Charles Marmar, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Neuroimaging; Positron emission tomography (PET); Post-traumatic Stress Disorder (PTSD); Kappa opioid receptor (KOR)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: S12-01521