CB1 Receptor PET Imaging Reveals Gender Differences in PTSD

NCT ID: NCT02237677

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-03-31

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.

Detailed 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.

Conditions

Post-traumatic Stress Disorder (PTSD)

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

Healthy Controls (HC)

Healthy Controls (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 (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

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.

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

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

12-02787

Identifier Type: -

Identifier Source: org_study_id