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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 Post Traumatic Stress Disorder and Traumatic Brain Injury, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04550377: Recruiting Phase 2 study of Post Traumatic Stress Disorder and Traumatic Brain Injury, sponsored by NYU Langone Health.
NCT04550377 is a Phase 2 study of Post Traumatic Stress Disorder and Traumatic Brain Injury that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 120 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04550377, a Phase 2 study of Post Traumatic Stress Disorder and Traumatic Brain Injury, 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.
Primary Outcome
Baseline - Week 8 change in Clinician-Administered PTSD Scale (CAPS-5) total score. The CAPS-5 is the gold standard clinician administered interview for diagnosing PTSD and assessing symptom severity. Total CAPS-5 scores range from 0-80. Higher scores indicate greater symptom severity.
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 |
What NCT04550377 shows while recruiting
NCT04550377 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04550377 reports a single indexed study location in 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: Post Traumatic Stress Disorder, Traumatic Brain Injury.
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.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04550377's enrollment target sits among peer trials
120 96th of 262 higher than 158 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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