We want to learn how an oral CBD product affects adults with moderate to severe restless legs syndrome (RLS). We want to find out about any side effects and changes in RLS symptoms, sleep, mood, and daily life.
RLS can make it hard to sleep and manage daily activities. Current treatments do not work well for everyone, and little is known about how CBD affects RLS. Our study may help understand whether CBD could be a future treatment option.
If you join, you will have a screening visit to see if the study is a good fit for you. The study team will ask about your health and medications. You will also have a physical exam and a heart test called an EKG. The study team will also collect some of your blood and urine to check your health. You will also fill out surveys to learn more about your symptoms and how they impact your daily life. If you can join, you will be placed by chance into one of two groups, like flipping a coin. Neither you nor the study team will know which group you are in. You will take either an oral CBD product or a placebo once a night for 20 days. A placebo looks like the CBD product but contains no CBD. Your dose will increase every five days until you reach the maximum dose of 600 mg of CBD or based on how you feel. During the study, the team will check your health and ask about your symptoms, medications, and any side effects. The study team will check your health by collecting a small amount of blood and urine from you. You will also fill out the same surveys you completed at the first visit. At two of the visits, you will wear a ring at home to track your sleep. You will need someone to drive you or another way to travel during the treatment period. Transportation vouchers may be provided.
Your participation will last about five to nine weeks. You will have five in-person clinic visits and three phone visits. This study includes 20 days of treatment.
You may be able to join if:
Protocol Number: 23-0682
Principal Investigator