Status:
TERMINATED
Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Yale University
Conditions:
Post-traumatic Stress Disorder (PTSD)
Trauma
Eligibility:
All Genders
18-55 years
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 investigator...
Eligibility Criteria
Inclusion
- Inclusion criteria for patients with PTSD:
- age 18-55 years old
- currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50.
- Exclusion criteria for patients with PTSD:
- any primary Axis I disorder other than PTSD (e.g. psychosis)
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
- 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
- current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
- current breast feeding
- 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
- 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
- general MRI exclusion criteria, i.e. pacemakers, metals in the body
- Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects);
- use of opioid medications within 2 weeks of the PET study
- 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
- seriously claustrophobic
- blood donation within 8 weeks prior to the study.
- Inclusion criteria for Healthy Subjects:
- age 18-55 years old
- no personal or first-degree family history of any Axis I diagnosis.
- Exclusion criteria for Healthy Subjects:
- any history or current primary Axis I disorder
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
- 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
- current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
- current breast feeding
- 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
- 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
- general MRI exclusion criteria, i.e. pacemakers, metals in the body
- HIV (due to possible neuropsychiatric effects)
- use of opioid medications within 2 weeks of the PET study
- having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study
- seriously claustrophobic
- blood donation within 8 weeks prior to the study
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02237703
Start Date
March 1 2012
End Date
August 1 2016
Last Update
January 20 2017
Active Locations (1)
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1
NYU School of Medicine
New York, New York, United States, 10016