Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder (TRAUMA-PRO)

Psychiatric University Hospital, Zurich

Status: Completed

Conditions: Physiological Stress; Intrusive Thought; Inflammatory Response; Psychological Trauma

Treatments: Drug: Dexmedetomidine; Behavioral: Experimental Model Trauma Film; Drug: Gamma-Hydroxybutyrate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04508166

TRAUMA-PROPHYLAXIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 3 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

Sublingual dose of dexmedetomidine

Treatment:

Behavioral: Experimental Model Trauma Film

Drug: Placebo

Drug: Dexmedetomidine

Gamma-hydroxybutyrate

Active Comparator group

Description:

Oral dose of gamma-hydroxybutyrate

Treatment:

Behavioral: Experimental Model Trauma Film

Drug: Gamma-Hydroxybutyrate

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Oral (saline) and sublingual (orodispersible tablet) doses

Treatment:

Behavioral: Experimental Model Trauma Film

Drug: Placebo

Drug: Dexmedetomidine