Clinical trial NCT04871269: The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories
Official title: The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intrusive Memories
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 291
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* healthy female volunteers
* German on a native level

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Intrusive Memories in the following four days after the intervention
timeFrame: four consecutive days
Secondary outcomes:
measure: Noradrenergic System (measured with salivary alpha-amylase - u/ml)
timeFrame: Day 1
measure: Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
timeFrame: Time Frame: Day 1
measure: Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories
timeFrame: Day 1
Other outcomes:
Locations:
city: Berlin-Steglitz
country: Germany
facility: Charité - Universitätsmedizin Berlin
state: Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan Röpke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Katja Wingenfeld, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: