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

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ClinicalTrials.gov Identifier: NCT02237703
Recruitment Status : Terminated (The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.)
First Posted : September 11, 2014
Last Update Posted : January 20, 2017
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
New York University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Post-traumatic Stress Disorder (PTSD) Trauma Other: Positron emission tomography (PET) imaging

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)
Study Start Date : March 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Post-traumatic stress disorder (PTSD)
Post-traumatic stress disorder (PTSD)
Other: Positron emission tomography (PET) imaging
Positron emission tomography (PET) imaging

Trauma Control (TC)
Trauma Control (TC)
Other: Positron emission tomography (PET) imaging
Positron emission tomography (PET) imaging

Healthy Control (HC)
Healthy Control (HC)
Other: Positron emission tomography (PET) imaging
Positron emission tomography (PET) imaging




Primary Outcome Measures :
  1. 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 [ Time Frame: Two months ]

    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.




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237703


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Yale University
Investigators
Principal Investigator: Charles Marmar, MD NYU School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02237703     History of Changes
Other Study ID Numbers: S12-01521
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by New York University School of Medicine:
Post-traumatic Stress Disorder (PTSD)
Positron emission tomography (PET)
Neuroimaging
Kappa opioid receptor (KOR)

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents