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Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

NCT04448808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bionorica SE

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Stefan Roepke, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2025-01-02
Completion
2025-01-02

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448808 on ClinicalTrials.gov