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

NCT ID: NCT02237703

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-08-31

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.

Conditions

Post-traumatic Stress Disorder (PTSD); Trauma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Post-traumatic stress disorder (PTSD)

Post-traumatic stress disorder (PTSD)

Positron emission tomography (PET) imaging

Intervention Type: OTHER

Positron emission tomography (PET) imaging

Trauma Control (TC)

Trauma Control (TC)

Positron emission tomography (PET) imaging

Intervention Type: OTHER

Positron emission tomography (PET) imaging

Healthy Control (HC)

Healthy Control (HC)

Positron emission tomography (PET) imaging

Intervention Type: OTHER

Positron emission tomography (PET) imaging

Interventions

Positron emission tomography (PET) imaging

Positron emission tomography (PET) imaging

Intervention Type: OTHER

Eligibility Criteria

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

12. seriously claustrophobic

13. blood donation within 8 weeks prior to the study.

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Marmar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

S12-01521

Identifier Type: -

Identifier Source: org_study_id