NCT04508166

Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder

Pharmacological Prevention of Post-traumatic Intrusions in Healthy Volunteers - Towards a Post-exposition Prophylaxis for Post-traumatic Stress Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Psychiatric University Hospital, Zurich · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.

Detailed description

The present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. The effects of a GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.

Conditions

• Intrusive Thought
• Psychological Trauma
• Inflammatory Response
• Physiological Stress

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory
DRUG	Gamma-Hydroxybutyrate	Volunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory
DRUG	Placebo	Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory
BEHAVIORAL	Experimental Model Trauma Film	Each volunteer views experimental model trauma film before scheduled bedrest in the sleep laboratory. This video is ca. 15 minutes in duration and is composed of short (a few seconds to a few minutes) individual and unrelated scenes of violent death and injury of varying description. Six versions of the film without re-occurring scenes will be presented in balanced order across drug order conditions.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-01-29
• Completion: 2022-01-29
• First posted: 2020-08-11
• Last updated: 2022-10-04

Locations

1 site across 1 country: Switzerland