The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories
- Conditions
- Intrusive Memories
- Interventions
- Drug: Placebo
- Registration Number
- NCT04871269
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief 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.
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 291
- healthy female volunteers
- German on a native level
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Drug: Dronabinol before the trauma film paradigm Placebo - Drug: Dronabinol after the trauma film paradigm Placebo - Placebo before and after the trauma film paradigm Placebo - Drug: Dronabinol before the trauma film paradigm Dronabinol - Drug: Dronabinol after the trauma film paradigm Dronabinol -
- Primary Outcome Measures
Name Time Method Change of Intrusive Memories in the following four days after the intervention four consecutive days Influence of dronabinol on the development of intrusive memories measured with an intrusion diary
- Secondary Outcome Measures
Name Time Method Noradrenergic System (measured with salivary alpha-amylase - u/ml) Day 1 Influence of dronabinol on the noradrenergic system measured with salivary alpha-amylase
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) Time Frame: Day 1 Influence of dronabinol on the HPA-axis measured with salivary cortisol
Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories Day 1 Influence of polygenic risk score on development of intrusive memories
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin
🇩🇪Berlin-Steglitz, Berlin, Germany