CBD for PTSD Research Study
Researchers at the University of Nebraska Medical Center are conducting a study in adults with PTSD that aims to understand the effects of an investigational medication (cannabidiol, CBD) on PTSD symptoms.
Fast Facts
Experiencing Symptoms of PTSD
21-65 Years Old
Compensation Provided
Conducted in Omaha, NE
Study Background
Is CBD safe and effective for treating PTSD?
Over the past decade, there has been increased interest in research around cannabidiol (CBD) to treat mental health disorders. CBD has a low risk of side effects and drug interactions and is much less likely than THC to present a risk of addiction, intoxication, or anxiety/psychotic symptoms.
In this 3-month research study, we want to examine the safety and effectiveness of a liquid structure formulation (softgel capsules) of CBD called Nantheia ATL-5 in individuals with PTSD. If you have had a traumatic event in your adult life and are now experiencing symptoms of PTSD, you could be eligible to participate.
Eventually, the findings of this study might be useful for treating PTSD and improving people’s quality of life.
Study Background
Is CBD safe and effective for treating PTSD?
Over the past decade, there has been increased interest in research around cannabidiol (CBD) to treat mental health disorders. CBD has a low risk of side effects and drug interactions, and is much less likely than THC to present a risk of addiction, intoxication, or anxiety/psychotic symptoms.
In this 3-month research study, we want to examine the safety and effectiveness of a liquid formulation of CBD called Nantheia ATL-5 in individuals with PTSD. If you have had a traumatic event in your adult life and are now experiencing symptoms of PTSD, you could be eligible to participate.
Eventually, the findings of this study might be useful for treating PTSD and improving people’s quality of life.
Additional Information
The purpose of the study is to understand how PTSD affects a person’s life and see if the study drug, Nantheia ATL5, can help improve symptoms of PTSD.
This research is not VA research, will not be conducted by VA, has not been reviewed by VA’s Institutional Review Board, and is not endorsed by VA. VA is not responsible for any costs incurred by a Veteran if the Veteran enters the study as a research subject.
The announcement is being provided for information only.
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- 21-65 years old
- Experienced a traumatic event at 18 years or older
- Current symptoms of PTSD
- If applicable, psychiatric medication or therapy has remained stable for 4 weeks
Exclusion Criteria:
- Diagnosed with moderate or severe substance or alcohol use disorder
- Pregnant or breastfeeding
Participation involves 8 study visits (1-6 hours) over 3 months. You will also be asked to wear a FitBit for the 3-month duration of the study.
Visits 1-2: Screening
Participants have a screening visit that is usually divided over 2 clinic appointments. One appointment reviews the study consent form, and confirms the diagnosis of PTSD and assesses symptom severity. The other reviews medical and psychiatric history, laboratory testing and vital signs. After screening there is a phone visit check-in.
Visit 3: Randomization
The third visit repeats the PTSD-specific assessments, laboratory testing and reviews medications and pre-existing conditions. Randomization (start of study treatment) happens at this visit. You will be randomly assigned either to take the study drug or a placebo.
Visits 4-7: Treatment
Following randomization there are 2 more phone visits (4 and 6) and 2 more in-person visits (5 and 7) where the PTSD assessments, laboratory testing and other assessments are completed. Study treatment ends at visit 7.
Visit 8: Follow-Up
Participants return 2 weeks later for a final visit, which includes PTSD symptom specific assessments and laboratory testing.
Study assessments are completed by trained psychiatric clinicians. A clinician is on-call outside of business hours.
Optional Procedures
Some optional procedures are offered during the informed consent process. These include:
- fMRI: before visit 3 and visit 7
- Blood banking for future research: completed at scheduled blood draw visits
Yes, you will be compensated for your time and effort. Additional compensation is provided for the optional fMRI procedures.
There is no cost for you to participate in our research study.
