Researchers are looking for adults with Alcohol Use Disorder (AUD) to learn how a type of brain stimulation called low-intensity focused ultrasound (LIFU) affects the brain and behavior.
LIFU is a type of brain stimulation that does not require surgery. It uses sound waves that you cannot hear to affect brain tissue. Researchers want to learn whether LIFU may help treat AUD. LIFU is not currently approved by the FDA for the treatment of AUD. The results of this research may help the study team better understand LIFU and its potential as a future treatment option. If you decide to join the study, you will have a first visit that will take about 2.5 to 3 hours to see if you qualify. During this visit, the study team will ask about your health history and background, review your identification, and have you fill out questionnaires. They will also collect blood and urine samples, check your vital signs, do a physical exam, and a breathalyzer test. If you qualify for the study, you will attend two scan visits. During each visit, you will have a magnetic resonance imaging (MRI) scan and receive either 10 minutes of LIFU or 10 minutes of sham stimulation. Sham stimulation means that the LIFU device will be placed on your head, but it will not send sound waves into your brain. At each visit, you will have an equal chance of getting real or sham stimulation, like flipping a coin. The MRI scan will help researchers see how different parts of your brain are working. After each scan, you will return to the clinic for a follow-up visit. You will complete tests and questionnaires about your health, alcohol use, sleep, and mood similar to those done at your first visit. You will have 5 in-person visits over 6 weeks. The two scan visits will each last about 2.5 hours, and the clinic visits will each last about 1 hour. There is no cost to take part in the study. If you complete all study visits, you may receive up to $500.
You may be able to join the study if you are 18 to 65 years old, have AUD, and drink at least 20 alcoholic drinks each week. You must not be looking for treatment to reduce or stop drinking, have any serious medical conditions, or take certain medications. If you can become pregnant, you must not be pregnant, breastfeeding, or planning to become pregnant during the study. The study team will review all eligibility requirements with you.
Protocol Number: 25-0695
Principal Investigator