Intrusive MemoriesNCT04871269
The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories
A study testing Dronabinol in people with Intrusive Memories, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Memories
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2021to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy female volunteers
- German on a native level
Who cannot join
- former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
- any physical illnesses
- any medication intake (except oral contraceptive)
- history of traumatic experience, e.g. history of sexual abuse or rape
- pregnancy or lactation period
- follicular phase of menstrual cycle for all women not using oral contraceptives
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin
Steglitz, State of Berlin, 10249
About this study
The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
Read the detailed description
Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD) after traumatic events. In own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (AEA) in BPD patients compared to healthy women (see Fig 1a). Furthermore, we found a correlation between hair concentrations of AEA and cortisol (p = .06; Fig 1b).
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 (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
- Conditions
- Intrusive Memories
- Being tested
- Dronabinol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Dronabinol
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Drug: Dronabinol before the trauma film paradigm | Experimental | Not described Receives: Drug: Dronabinol; Drug: Placebo |
| Drug: Dronabinol after the trauma film paradigm | Experimental | Not described Receives: Drug: Dronabinol; Drug: Placebo |
| Placebo before and after the trauma film paradigm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Intrusive Memories in the following four days after the intervention
Influence of dronabinol on the development of intrusive memories measured with an intrusion diary
Measured: four consecutive days
Secondary outcomes (3)
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Influence of dronabinol on the noradrenergic system measured with salivary alpha-amylase
Measured: Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Influence of dronabinol on the HPA-axis measured with salivary cortisol
Measured: Time Frame: Day 1
Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories
Influence of polygenic risk score on development of intrusive memories
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion28 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive MemoriesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 291 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
- Investigators
- Stefan Röpke, Prof. Dr., Principal investigator, Charite University, Berlin, GermanyKatja Wingenfeld, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871269
- Sponsor's protocol ID
- DroMemo
- Status last verified
- Mar 2025
- First submitted
- 3 May 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
- The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories
- ClinicalTrials.gov ID
- NCT04871269
- Acronym / sponsor ID
- DroMemo
- Conditions
- Intrusive Memories
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 4 May 2021 (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.
The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
Detailed description
Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD) after traumatic events. In own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (AEA) in BPD patients compared to healthy women (see Fig 1a). Furthermore, we found a correlation between hair concentrations of AEA and cortisol (p = .06; Fig 1b).
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 (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug: Dronabinol before the trauma film paradigm | Experimental | Drug: Dronabinol, Drug: Placebo |
| Drug: Dronabinol after the trauma film paradigm | Experimental | Drug: Dronabinol, Drug: Placebo |
| Placebo before and after the trauma film paradigm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy female volunteers
- German on a native level
Key exclusion criteria (6 listed)
- former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
- any physical illnesses
- any medication intake (except oral contraceptive)
- history of traumatic experience, e.g. history of sexual abuse or rape
- pregnancy or lactation period
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 |
|---|---|---|
| DronabinolDronabinol | Drug | Drug: Dronabinol after the trauma film paradigm, Drug: Dronabinol before the trauma film paradigm |
| PlaceboPlacebo | Drug | Drug: Dronabinol after the trauma film paradigm, Drug: Dronabinol before the trauma film paradigm, Placebo before and after the trauma film paradigm |
Primary outcome
Change of Intrusive Memories in the following four days after the intervention
Time frame: four consecutive days
Influence of dronabinol on the development of intrusive memories measured with an intrusion diary
3 secondary outcomes
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Time frame: Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Time frame: Time Frame: Day 1
Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Stefan Röpke, Prof. Dr. principal investigator
Charite University, Berlin, Germany
Katja Wingenfeld, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dronabinol in people with Intrusive Memories, run by Charite University, Berlin, Germany at 1 site 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 2 inclusion and 6 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: under way, not looking for participants, 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Change of Intrusive Memories in the following four days after the intervention (time frame: four consecutive days). 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.