Looking out for one another
We want to find new ways to support Veterans. Participating in clinical research helps us test new treatments. A Veteran-founded company is sponsoring this study to help other Veterans.
We want to see whether cannabigerol (CBG) can help Veterans sleep better. In the Veterans ECS21 Study, you can participate in cutting-edge research that could help other Veterans. If you are eligible to participate, then you will be given a Fitbit that is yours to keep after the study.
What is the purpose of this study?
This research is studying whether CBG can improve sleep for US Veterans. Metta Medical (the maker of LEVEL products) is sponsoring this research study, and the founder of Metta Medical is also a US Veteran.
We want to find out if taking CBG changes the way you sleep. We will study this effect by asking you to wear a Fitbit and answer questions through a study application (app).
What do I need to do in the study?
If you are eligible to participate, then you will be given a Fitbit that is yours to keep after the study. We will use the information from your Fitbit to see how taking CBG changes your activity, sleep, and heart rate.
During the study, you’ll wear the Fitbit and use an app to answer surveys about your day, how you feel, your habits in terms of taking drugs and drinking alcohol, and how you take care of yourself. The questions in the study app will help us learn more about you and your personal experiences. There are no right or wrong answers because everyone’s experience is unique. How you respond to these questions will not go on your medical record or be reported to Veterans Affairs; this information will be used for this research study only. On average, the surveys will take less than five minutes per day.
You’ll be randomly assigned to receive either a CBG tablet or a placebo (a tablet with no CBG). CBG does not get you high. The use of CBG in this study is investigational. The US Food and Drug Administration (FDA) has not approved CBG for the treatment of sleep problems.
The study will take approximately seven to eight weeks, and we are recruiting about 110 participants.
WHAT IS CLINICAL RESEARCH?
Clinical research consists of voluntary studies designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
DO I HAVE TO STOP TAKING OTHER MEDICATIONS TO PARTICIPATE IN THE STUDY?
No. We’ll ask you what medications you are taking, but you don’t have to change any medications to participate.
DO I HAVE TO STOP TAKING OTHER TYPES OF CANNABIS TO PARTICIPATE IN THE STUDY?
No. However, you won’t be able to participate if you already take CBG. You can continue to use other forms of cannabis, including cannabis containing THC.
WHAT IF I USE A PAP (POSITIVE AIRWAY PRESSURE) OR CONTINUOUS PAP (CPAP) DEVICE TO HELP ME SLEEP?
If you currently use a PAP or CPAP device and have been using it for at least four weeks, then you can participate in the study.
Who is eligible?
You may be eligible for this study if you:
- are a military Veteran who has trouble sleeping,
- are age 21 or older,
- are a current resident of California,
- have a smartphone with stable internet access that you can use for the study app, and
- can complete study activities for seven to eight weeks.
It’s important to note this study will not provide any diagnosis or support for medical problems. If you experience health problems, then you should seek appropriate help. We’ve listed a few sources below.
- Call the Veterans Crisis Line at 1-800-273-8255 and press 1, or text 838255.
- If you are having suicidal thoughts or feel you are in crisis, then you can call 911 and/or a nationwide suicide hotline that is answered 24/7 and speak with a trained counselor. One example is the National Suicide Prevention Lifeline at 1-800-273-TALK (8255).
- You can go to your closest emergency room.
Ready to join?
To speak with the study team for more information, you can email us at ECS21@curebase.com or call 415.612.3779.
For more information on clinical research, we recommend visiting Clinical Trials: What Patients Need to Know, an online FDA resource.
