Post Traumatic Stress DisorderDronaMemo-2NCT05226351
Activation of the Endocannabinoid System and Cognition
A study testing Dronabinol 2.5 mg in people with Post Traumatic Stress Disorder, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Dronabinol 2.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Mar 2022to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PTSD criteria fullfilled (patients only)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Universitätsmedizin Berlin
Berlin, 12203
Charite University
Berlin
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Dronabinol 2.5 mg, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol 2.5 mgDrug
single administration of 2.5mg Dronabinol oral (oily solution)
PlaceboDrug
single administration of placebo oral (oily solution)
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol PTSD | Active comparator | Donabinol before cognitve testing - PTSD patients Receives: Drug: Dronabinol 2.5 mg |
| Dronabinol healthy controls | Active comparator | Donabinol before cognitve testing - healthy controls Receives: Drug: Dronabinol 2.5 mg |
| Placebo PTSD | Placebo comparator | Placebo before cognitve testing - PTSD patients Receives: Drug: Placebo |
| Placebo healthy controls | Placebo comparator | Placebo before cognitve testing - healthy controls Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
extinction learning
extinction learning in fear conditioning paradigm: skin conductance reaction
Measured: 30 minutes
Secondary outcomes (3)
empathy
cognitive and emotional empathy: number of correct answers \& rating of own emotional state
Measured: 15 minutes
Probabilistic Reversal Learning Task
learning and cognitive flexibility: reaction times
Measured: 15 minutes
selective attention
emotional dot-probe task: attentional bias index
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Mar 2022
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Roepke, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226351
- Sponsor's protocol ID
- WI 3396/14-1 // RO 3935/7-1
- Acronym
- DronaMemo-2
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)
- ClinicalTrials.gov ID
- NCT05226351
- Acronym / sponsor ID
- DronaMemo-2 / WI 3396/14-1 // RO 3935/7-1
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dronabinol PTSD | Active comparator | Drug: Dronabinol 2.5 mgDonabinol before cognitve testing - PTSD patients |
| Dronabinol healthy controls | Active comparator | Drug: Dronabinol 2.5 mgDonabinol before cognitve testing - healthy controls |
| Placebo PTSD | Placebo comparator | Drug: PlaceboPlacebo before cognitve testing - PTSD patients |
| Placebo healthy controls | Placebo comparator | Drug: PlaceboPlacebo before cognitve testing - healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PTSD criteria fullfilled (patients only)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol 2.5 mgsingle administration of 2.5mg Dronabinol oral (oily solution) | Drug | Dronabinol PTSD, Dronabinol healthy controls |
| Placebosingle administration of placebo oral (oily solution) | Drug | Placebo PTSD, Placebo healthy controls |
Primary outcome
extinction learning
Time frame: 30 minutes
extinction learning in fear conditioning paradigm: skin conductance reaction
3 secondary outcomes
empathy
Time frame: 15 minutes
Probabilistic Reversal Learning Task
Time frame: 15 minutes
selective attention
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dronabinol 2.5 mg in people with Post Traumatic Stress Disorder, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extinction learning (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.