Activation of the Endocannabinoid System and Cognition
DronaMemo-2
1 other identifier
interventional
192
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedMarch 10, 2025
August 1, 2024
2.5 years
April 29, 2021
March 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
extinction learning
extinction learning in fear conditioning paradigm: skin conductance reaction
30 minutes
Secondary Outcomes (3)
empathy
15 minutes
Probabilistic Reversal Learning Task
15 minutes
selective attention
10 minutes
Study Arms (4)
Dronabinol PTSD
ACTIVE COMPARATORDonabinol before cognitve testing - PTSD patients
Dronabinol healthy controls
ACTIVE COMPARATORDonabinol before cognitve testing - healthy controls
Placebo PTSD
PLACEBO COMPARATORPlacebo before cognitve testing - PTSD patients
Placebo healthy controls
PLACEBO COMPARATORPlacebo before cognitve testing - healthy controls
Interventions
single administration of 2.5mg Dronabinol oral (oily solution)
single administration of placebo oral (oily solution)
Eligibility Criteria
You may qualify if:
- PTSD criteria fullfilled (patients only)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
Charite University
Berlin, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- blinding
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Stefan Röpke
Study Record Dates
First Submitted
April 29, 2021
First Posted
February 7, 2022
Study Start
March 1, 2022
Primary Completion
August 15, 2024
Study Completion
August 15, 2024
Last Updated
March 10, 2025
Record last verified: 2024-08