CB1 Receptor PET Imaging Reveals Gender Differences in PTSD

NCT02237677 | Terminated DMC

• 1 other identifier: 12-02787
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the proposed translational study is to test a model, based upon basic science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB) and glucocorticoids in the modulation of fear memories by examining the cannabinoid type 1 (CB1) receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators propose that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral response to the stressor is associated with an upregulation of the CB1 receptors and insufficient glucocorticoid signaling.

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Post-traumatic stress disorder (PTSD); Trauma; Neuroimaging; Positron emission tomography (PET); [11C]OMAR; Endocannabinoid

Outcome Measures

Primary Outcomes (1)

• Volume of distribution (VT) of cerebral CB1 receptor expression in PTSD and controls within a fear circuit of brain regions that regulate stress-related behaviors using the CB1 radioligand carbon - 11 (11C) [11C]OMAR and PET.

  To examine group differences in cerebral CB1 receptor expression in PTSD and controls within a fear circuit of cortical and subcortical brain regions that regulate stress-related behaviors using the CB1 radioligand \[11C\]OMAR and PET. Hypothesis: PTSD patients will show greater \[11C\]OMAR VT (i.e. CB1 binding) values than both control groups, trauma-exposed and non-trauma exposed control subjects who will not be different.

  Two months

Study Arms (2)

Post-traumatic stress disorder (PTSD)

Post-traumatic stress disorder (PTSD)

Other: Positron emission tomography (PET) imaging

Healthy Controls (HC)

Healthy Controls (HC)

Other: Positron emission tomography (PET) imaging

Interventions

Positron emission tomography (PET) imaging OTHER

Positron emission tomography (PET) imaging

Healthy Controls (HC); Post-traumatic stress disorder (PTSD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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, history of post-traumatic stress disorder (PTSD) or healthy control.

You may qualify if:

• age 18-55 years old
• currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50.
• age 18-55 years old
• no personal or first-degree family history of any Axis I diagnosis.

You may not qualify if:

• 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 (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
• nicotine dependence
• suicidal ideation or behavior
• 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 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.
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Yale University: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Charles Marmar, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: June 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)