NCT04448808

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol: A Randomized Controlled Study (THC PTSD-trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled exploratory phase II trial will test the hypothesis that oral dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	BX-1	BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
DRUG	Placebo	Placebo of BX-1, oral solution

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-01-02
• Completion: 2025-01-02
• First posted: 2020-06-26
• Last updated: 2025-08-13

Locations

4 sites across 1 country: Germany