Activation of the Endocannabinoid System and Cognition (DronaMemo-2)

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

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Dronabinol 2.5 mg

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 Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charite University
  • Berlin, Germany, 12203
    • Charité Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: WI 3396/14-1 // RO 3935/7-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No