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NCT04550377 · ClinicalTrials.gov registry record · Phase 2
Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
A Phase 2 study of Traumatic Brain Injury and Post Traumatic Stress Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04550377 is a Phase 2 study of Traumatic Brain Injury and Post Traumatic Stress Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 120 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04550377, a Phase 2 study of Traumatic Brain Injury and Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD). Subjects, 120 in total, will be males and females with PTSD, half of which will have comorbid mild traumatic brain injury (TBI). There will be three study arms, each with 40 subjects: 1) Oral CBD 400 mg daily; 2) Oral CBD 800 mg daily, and 3) Placebo daily. Treatment duration will be 8 weeks. The primary outcome will be change in PTSD symptoms as measured by change in the Clinician-Administered PTSD Scale (CAPS-5) total score.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cannabidiol
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04550377
The ClinicalTrials.gov registry entry for NCT04550377 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (57% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04550377 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04550377 about?
NCT04550377 is a clinical study titled "Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI". This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD). Subjects, 120 in total, will be males and females with PTSD, half of which will have comorbid mild traumatic brain injury (TBI). There wi...
What is the current status of trial NCT04550377?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2021-05-26. Estimated completion is 2026-06.
What conditions does trial NCT04550377 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT04550377?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT04550377?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04550377 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.