Activation of the Endocannabinoid System and Cognition

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: Placebo; Drug: Dronabinol 2.5 mg

• Registration Number: NCT05226351
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-07
• Study Start: 2022-03-01
• Status Verified: 2024-08
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo PTSD	Placebo	Placebo before cognitve testing - PTSD patients
Placebo healthy controls	Placebo	Placebo before cognitve testing - healthy controls
Dronabinol healthy controls	Dronabinol 2.5 mg	Donabinol before cognitve testing - healthy controls
Dronabinol PTSD	Dronabinol 2.5 mg	Donabinol before cognitve testing - PTSD patients

Primary Outcome Measures

Name	Time	Method
extinction learning	30 minutes	extinction learning in fear conditioning paradigm: skin conductance reaction

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Charite University; 🇩🇪 Berlin, Germany