NCT04871269

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intrusive Memories

Interventions

Type	Name	Description
DRUG	Dronabinol	Dronabinol
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-31
• Completion: 2025-08-28
• First posted: 2021-05-04
• Last updated: 2025-03-10

Locations

1 site across 1 country: Germany