Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial).
Stefan Roepke, Nikola Schoofs, Kathlen Priebe, Felix Wülfing, Christian Schmahl, Robert Röhle, Jenny Zähringer, Tobias Lotter, Christian Otte, Stefanie Koglin
BMC Psychiatry May 5, 2023 DOI: 10.1186/s12888-023-04818-5 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Population | Patients with posttraumatic stress disorder (PTSD) and distressing nightmares |
| Interventions | Dronabinol (BX-1) placebo |
| Duration | 10 weeks of once-daily treatment |
| Measures | Clinician-Administered PTSD Scale (CAPS-IV) B2 score |
| Topics | Cannabis Dreaming PTSD |
| Keywords | Bx-1 Clinical trial protocol Dronabinol Nightmares Posttraumatic stress disorder Randomized clinical trial |
| Registration | NCT04448808 |
| Key findings | The protocol proposes a multicenter, double-blind, randomized, placebo-controlled trial to test whether oral dronabinol (BX-1), taken once daily before bedtime for 10 weeks, reduces nightmares and other PTSD symptoms in patients with PTSD. The primary outcome is the CAPS-IV B2 score for the last week; tolerability and safety will also be assessed. The authors state that preliminary clinical data suggest cannabinoid agonists can improve nightmares and overall PTSD symptoms, but no specific pharmacological treatment for PTSD-related nightmares is approved. |
Abstract
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. 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. This randomized controlled trial will provide evidence whether treating patients with PTSD and nightmares with dronabinol is safe and efficacious. NCT04448808, EudraCT 2019-002211-25.
Comparable studies
Other randomized controlled trials on PTSD, most cited first.
Citations in the library
Cited by 2
Cites 5
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