Activation of the Endocannabinoid System and Cognition

Post Traumatic Stress Disorder Clinical Trial

— DronaMemo-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226351
• Other study ID #: WI 3396/13-1 // RO 3935/6-1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Stefan Röpke, Dr. med.
• Phone: 0049 30 450 517545
• Email: stefan.roepke[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Dronabinol 2.5 mg
single administration of 2.5mg Dronabinol oral (oily solution)
• Placebo
single administration of placebo oral (oily solution)

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extinction learning	extinction learning in fear conditioning paradigm: skin conductance reaction	30 minutes
Secondary	empathy	cognitive and emotional empathy: number of correct answers & rating of own emotional state	15 minutes
Secondary	Probabilistic Reversal Learning Task	learning and cognitive flexibility: reaction times	15 minutes
Secondary	selective attention	emotional dot-probe task: attentional bias index	10 minutes