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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226351
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Stefan Roepke, 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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Dronabinol 5 mg Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

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)




Primary Outcome Measures :
  1. extinction learning [ Time Frame: 30 minutes ]
    extinction learning in fear conditioning paradigm: skin conductance reaction


Secondary Outcome Measures :
  1. empathy [ Time Frame: 15 minutes ]
    cognitive and emotional empathy: number of correct answers & rating of own emotional state

  2. Probabilistic Reversal Learning Task [ Time Frame: 15 minutes ]
    learning and cognitive flexibility: reaction times

  3. selective attention [ Time Frame: 10 minutes ]
    emotional dot-probe task: attentional bias index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226351


Contacts
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Contact: Stefan Röpke, Dr. med. 0049 30 450 517545 stefan.roepke@charite.de
Contact: Katja Wingenfeld, Dr. rer.nat. 0049 30 450 517534 katja.wingenfeld@charite.de

Locations
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Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12203
Contact: Stefan Röpke, Dr. med.    0049 30 450 517545    stefan.roepke@charite.de   
Contact: Katja Wingenfeld, Dr. rer.nat.    0049 30 450 517534    katja.wingenfeld@charite.de   
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 12203
Contact: Stefan Röpke, Dr. med.    0049 30 450 517545    stefan.roepke@charite.de   
Contact: Katja Wingenfeld, Dr. rer.nat.    0049 30 450 517534    katja.wingenfeld@charite.de   
Charite University Recruiting
Berlin, Germany
Contact: Katja Wingenfeld, PhD    004930450517534    katja.wingenfeld@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
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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: February 7, 2022    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists