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

NCT04508166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-10-04

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Psychiatric University Hospital, Zurich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-01-29
Completion
2022-01-29

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508166 on ClinicalTrials.gov