Activation of the Endocannabinoid System and Cognition

Study Overview
=================
Brief Summary
-----------------
Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.

Detailed Description
-----------------
Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.

Official Title
-----------------
Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: Dronabinol 2.5 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD criteria fullfilled (patients only) Exclusion Criteria: All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded. Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded. psychiatric disorder according to DSM-5 (healthy controls only)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dronabinol PTSD<br>Donabinol before cognitve testing - PTSD patients | Drug: Dronabinol 2.5 mg<br>* single administration of 2.5mg Dronabinol oral (oily solution)<br>|
| Active Comparator: Dronabinol healthy controls<br>Donabinol before cognitve testing - healthy controls | Drug: Dronabinol 2.5 mg<br>* single administration of 2.5mg Dronabinol oral (oily solution)<br>|
| Placebo Comparator: Placebo PTSD<br>Placebo before cognitve testing - PTSD patients | Drug: Placebo<br>* single administration of placebo oral (oily solution)<br>|
| Placebo Comparator: Placebo healthy controls<br>Placebo before cognitve testing - healthy controls | Drug: Placebo<br>* single administration of placebo oral (oily solution)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extinction learning | extinction learning in fear conditioning paradigm: skin conductance reaction | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| empathy | cognitive and emotional empathy: number of correct answers & rating of own emotional state | 15 minutes | 
| Probabilistic Reversal Learning Task | learning and cognitive flexibility: reaction times | 15 minutes | 
| selective attention | emotional dot-probe task: attentional bias index | 10 minutes |