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Open Access 01-12-2023 | Dronabinol | Study Protocol

Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial)

Authors: Stefan Roepke, Nikola Schoofs, Kathlen Priebe, Felix Wülfing, Christian Schmahl, Robert Röhle, Jenny Zähringer, Tobias Lotter, Christian Otte, Stefanie Koglin

Published in: BMC Psychiatry | Issue 1/2023

Abstract

Background

Distressing nightmares are a core symptom of posttraumatic stress disorder (PTSD) and contribute to psychiatric comorbidity, impaired physical health and decreased social functioning. No specific pharmacological treatment for PTSD-related nightmares is yet approved. Preliminary clinical data indicate that cannabinoid agonists can improve nightmares and overall PTSD symptoms in patients with PTSD. The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD. The secondary objectives of the study are to examine the efficacy of oral BX-1 in reducing other PTSD symptoms.

Methods

The study is designed as a multi-centric, double-blind, randomized (1:1), placebo-controlled, parallel group interventional trial. Eligible patients will be randomized to BX-1 or placebo, receiving a once-daily oral dose before bedtime for 10 weeks. Primary efficacy endpoint is the Clinician-Administered PTSD Scale (CAPS-IV) B2 score for the last week, measuring frequency and intensity of nightmares. Secondary efficacy endpoints are other disorder-specific symptoms in patients with PTSD. Further, tolerability and safety of dronabinol will be assessed.

Discussion

This randomized controlled trial will provide evidence whether treating patients with PTSD and nightmares with dronabinol is safe and efficacious.

Trial registration

NCT04448808, EudraCT 2019–002211-25.

Available only for authorised users

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Title: Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial)
Authors: Stefan Roepke
Nikola Schoofs
Kathlen Priebe
Felix Wülfing
Christian Schmahl
Robert Röhle
Jenny Zähringer
Tobias Lotter
Christian Otte
Stefanie Koglin
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Dronabinol
Published in: BMC Psychiatry / Issue 1/2023
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-023-04818-5

At a glance: The STEP trials

Springer Medicine

Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial)

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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