DronaMemo-2: Activation of the Endocannabinoid System and Cognition

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT05226351

Collaborator

(none)

180

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Drug: Dronabinol 5 mg Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

blinding

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dronabinol PTSD Donabinol before cognitve testing - PTSD patients	Drug: Dronabinol 5 mg single administration of 5mg Dronabinol oral (oily solution)
Active Comparator: Dronabinol healthy controls Donabinol before cognitve testing - healthy controls	Drug: Dronabinol 5 mg single administration of 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)

Outcome Measures

Primary Outcome Measures

extinction learning [30 minutes]
extinction learning in fear conditioning paradigm: skin conductance reaction

Secondary Outcome Measures

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
selective attention [10 minutes]
emotional dot-probe task: attentional bias index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charité Universitätsmedizin Berlin	Berlin	Germany	12203
2	Charité Universitätsmedizin Berlin	Berlin	Germany	12203
3	Charite University	Berlin	Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefan Roepke, Prof. Dr. Stefan Röpke, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT05226351

Other Study ID Numbers:

WI 3396/13-1 // RO 3935/6-1

First Posted:

Feb 7, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Dronabinol

Study Results

No Results Posted as of May 2, 2022