The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories

Intrusive Memories Clinical Trial

Official title:

The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871269
• Other study ID #: DroMemo
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 28, 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Tolou Maslahati, M.Sc.
• Phone: 0049 030 450 517 567
• Email: tolou.maslahati[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 291
• Est. completion date: August 28, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrusive Memories

Intervention

Drug:
• Dronabinol
Dronabinol
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin-Steglitz	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	four consecutive days
Secondary	Noradrenergic System (measured with salivary alpha-amylase - u/ml)	Influence of dronabinol on the noradrenergic system measured with salivary alpha-amylase	Day 1
Secondary	Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)	Influence of dronabinol on the HPA-axis measured with salivary cortisol	Time Frame: Day 1
Secondary	Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories	Influence of polygenic risk score on development of intrusive memories	Day 1