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

Autor: Roepke S; Department of Psychiatry and Neurosciences, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany. Stefan.roepke@charite.de.; Oberberg Fachkliniken for Psychiatry, Psychosomatics and Psychotherapy, Berlin and Brandenburg, Germany. Stefan.roepke@charite.de., Schoofs N; Department of Psychiatry and Neuroscience, Charité Universitätsmedizin Berlin, Charité Campus Mitte, Berlin, Germany., Priebe K; Department of Psychiatry and Neuroscience, Charité Universitätsmedizin Berlin, Charité Campus Mitte, Berlin, Germany., Wülfing F; Department of Psychiatry and Neuroscience, Charité Universitätsmedizin Berlin, Charité Campus Mitte, Berlin, Germany., Schmahl C; Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany., Röhle R; Charité - Universitätsmedizin Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Germany., Zähringer J; Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany., Lotter T; Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.; Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany., Otte C; Department of Psychiatry and Neurosciences, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany., Koglin S; Department of Psychiatry and Neurosciences, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Jazyk: angličtina
Zdroj: BMC psychiatry [BMC Psychiatry] 2023 May 05; Vol. 23 (1), pp. 319. Date of Electronic Publication: 2023 May 05.
DOI: 10.1186/s12888-023-04818-5
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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