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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02237703
• Other study ID #: S12-01521
• Status: Terminated
• Phase: N/A
• First received: September 9, 2014
• Last updated: January 19, 2017
• Start date: March 2012
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma

Intervention

Other:
• Positron emission tomography (PET) imaging
Positron emission tomography (PET) imaging

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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