CB1 Receptor PET Imaging Reveals Gender Differences in PTSD

Post-traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Cannabinoid-1 (CB1) Receptor Positron Emission Tomography (PET) Imaging Reveals Gender Differences in Posttraumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02237677
• Other study ID #: 12-02787
• Status: Terminated
• Phase: N/A
• First received: September 9, 2014
• Last updated: August 15, 2016
• Start date: June 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

The eCB - anandamide and 2-arachidonoylglycerol (2-AG) - and their attending cannabinoid (CB) receptors which are found in high densities in a fear circuitry involving the amygdala, hippocampus, the anterior cingulate cortex and prefrontal cortex serve important functions in the regulation of stress-coping behaviors. Besides eCB regulation there is strong evidence from ongoing research of the investigators group and others suggesting an important role for glucocorticoid signaling as an endpoint of the biochemical sequelae initiated by stressful or aversive stimuli. One of the long-term research goals of our lab is to understand such functions and determine their relevance to the pathogenesis of PTSD and to provide a more integrative view on neurobiological mechanisms that are involved in the regulation of the neuroadaptive response to stress. The objective of the proposed translational study is to test a model, based upon basic science studies, exploring multisystem impairments in PTSD including eCB and glucocorticoids in the modulation of fear memories by examining the 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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.

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 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 (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. nicotine dependence

7. suicidal ideation or behavior

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 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.

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. nicotine dependence

7. suicidal ideation or behavior

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

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 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	No