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NCT05269459 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults
A Phase 2 study of PTSD, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT05269459: Recruiting Phase 2 study of PTSD, sponsored by University of Nebraska.
NCT05269459 is a Phase 2 study of PTSD that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 180 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269459, a Phase 2 study of PTSD, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).
Primary Outcome
Structured clinician-administered rating of post-traumatic stress disorder (PTSD) symptoms' severity using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; CAPS-5) Scale. This instrument assesses 20 PTSD symptoms. Each symptom is scored 0 - 4, then symptom scores are totaled. Higher scores indicate greater symptom severity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cannabidiol Administered as Nantheia ATL5
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2029-04 |
| Phase | Phase 2 |
What NCT05269459 shows while recruiting
NCT05269459 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (40% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05269459 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05269459 about?
NCT05269459 is a clinical study titled "Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults". Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experien...
What is the current status of trial NCT05269459?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2022-12-01. Estimated completion is 2029-04.
What conditions does trial NCT05269459 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT05269459?
The interventions under investigation include: Placebo (DRUG), Cannabidiol Administered as Nantheia ATL5 (DRUG).
Who is sponsoring clinical trial NCT05269459?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05269459 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
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 NCT05269459's enrollment target sits among peer trials
180 32nd of 154 higher than 120 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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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