search
Back to results

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

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dronabinol 2.5 mg
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Charité Universitätsmedizin BerlinRecruiting
  • Charité Universitätsmedizin Berlin
  • Charite UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Dronabinol PTSD

Dronabinol healthy controls

Placebo PTSD

Placebo healthy controls

Arm Description

Donabinol before cognitve testing - PTSD patients

Donabinol before cognitve testing - healthy controls

Placebo before cognitve testing - PTSD patients

Placebo before cognitve testing - healthy controls

Outcomes

Primary Outcome Measures

extinction learning
extinction learning in fear conditioning paradigm: skin conductance reaction

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2021
Last Updated
March 31, 2023
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT05226351
Brief Title
Activation of the Endocannabinoid System and Cognition
Acronym
DronaMemo-2
Official Title
Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Masking Description
blinding
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dronabinol PTSD
Arm Type
Active Comparator
Arm Description
Donabinol before cognitve testing - PTSD patients
Arm Title
Dronabinol healthy controls
Arm Type
Active Comparator
Arm Description
Donabinol before cognitve testing - healthy controls
Arm Title
Placebo PTSD
Arm Type
Placebo Comparator
Arm Description
Placebo before cognitve testing - PTSD patients
Arm Title
Placebo healthy controls
Arm Type
Placebo Comparator
Arm Description
Placebo before cognitve testing - healthy controls
Intervention Type
Drug
Intervention Name(s)
Dronabinol 2.5 mg
Intervention Description
single administration of 2.5mg Dronabinol oral (oily solution)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single administration of placebo oral (oily solution)
Primary Outcome Measure Information:
Title
extinction learning
Description
extinction learning in fear conditioning paradigm: skin conductance reaction
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
empathy
Description
cognitive and emotional empathy: number of correct answers & rating of own emotional state
Time Frame
15 minutes
Title
Probabilistic Reversal Learning Task
Description
learning and cognitive flexibility: reaction times
Time Frame
15 minutes
Title
selective attention
Description
emotional dot-probe task: attentional bias index
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Röpke, Dr. med.
Phone
0049 30 450 517545
Email
stefan.roepke@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Katja Wingenfeld, Dr. rer.nat.
Phone
0049 30 450 517534
Email
katja.wingenfeld@charite.de
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Röpke, Dr. med.
Phone
0049 30 450 517545
Email
stefan.roepke@charite.de
First Name & Middle Initial & Last Name & Degree
Katja Wingenfeld, Dr. rer.nat.
Phone
0049 30 450 517534
Email
katja.wingenfeld@charite.de
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Röpke, Dr. med.
Phone
0049 30 450 517545
Email
stefan.roepke@charite.de
First Name & Middle Initial & Last Name & Degree
Katja Wingenfeld, Dr. rer.nat.
Phone
0049 30 450 517534
Email
katja.wingenfeld@charite.de
Facility Name
Charite University
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Wingenfeld, PhD
Phone
004930450517534
Email
katja.wingenfeld@charite.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Activation of the Endocannabinoid System and Cognition

We'll reach out to this number within 24 hrs