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

NCT ID: NCT04508166

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-01-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

Sublingual dose of dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory

Placebo

Intervention Type: DRUG

Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory

Experimental Model Trauma Film

Intervention Type: BEHAVIORAL

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.

Gamma-hydroxybutyrate

Oral dose of gamma-hydroxybutyrate

Group Type: ACTIVE_COMPARATOR

Gamma-Hydroxybutyrate

Intervention Type: DRUG

Volunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory

Placebo

Intervention Type: DRUG

Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory

Experimental Model Trauma Film

Intervention Type: BEHAVIORAL

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.

Placebo

Oral (saline) and sublingual (orodispersible tablet) doses

Group Type: PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory

Placebo

Intervention Type: DRUG

Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory

Experimental Model Trauma Film

Intervention Type: BEHAVIORAL

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.

Interventions

Dexmedetomidine

Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory

Intervention Type: DRUG

Gamma-Hydroxybutyrate

Volunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory

Intervention Type: DRUG

Placebo

Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Dexdor; Xyrem

Eligibility Criteria

Inclusion Criteria

• Speaks and understands German
• BMI 18.5 -< 25
• Non-smoker status
• Habitual 5 or fewer alcoholic beverages / week
• Habitual 3 or fewer caffeinated beverages / day
• Habitual average sleep duration 7-9 h / night
• Normal or corrected-to-normal vision
• Insomnia Severity Index score between 8-14

Exclusion Criteria

• Travel across 3 or more time zones within 3 months of study start
• Habitual napping
• Extreme chronotype, determined by Morningness-Eveningness Questionnaire
• History of or presence of a trauma- or stressor-related disorder
• History of or presence of neurological disorder, psychiatric disorder or head injury
• History of or presence of a sleep disorder
• History of or presence of cardiovascular disorder
• Use of illicit drugs
• Atypical preference for excessively violent portrayals
• Faints at the site of blood or brutality
• Has participated in a study < 30 days or a study such as this (i.e., experimental trauma) at all.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Psychiatric University Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Zurich

Zurich, Select An Option…, Switzerland

Countries

Switzerland

Other Identifiers

TRAUMA-PROPHYLAXIS

Identifier Type: -

Identifier Source: org_study_id