RecruitingPhase 2NCT05269459

Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults

Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).


Sponsor

University of Nebraska

Enrollment

180 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether cannabidiol (CBD) — a non-intoxicating compound from cannabis — can reduce PTSD symptoms in adults. Participants with PTSD will be compared to healthy volunteers. **You may be eligible if...** - You are 21–65 years old and able to read and communicate in English - You have a current diagnosis of PTSD with symptoms for at least 1 month - Your PTSD symptoms score at or above a clinical threshold on a standard assessment - You use marijuana/THC fewer than 3 days per week - Any psychiatric medication or therapy has been stable for at least 4 weeks **You may NOT be eligible if...** - You currently use CBD products (including Epidiolex) - You have active thoughts of suicide - You have significant liver disease or liver enzyme abnormalities - You use THC 3 or more days per week - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCannabidiol Administered as Nantheia ATL5

Participants will take 4 gel capsules twice daily containing 100mg of Nantheia ATL5.

DRUGPlacebo

Participants will take 4 matching gel capsules twice daily containing no active drug.


Locations(1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05269459


Related Trials