We want to learn how a new drug called brexpiprazole (BREX) affects alcohol use and brain function in adults who are not currently getting treatment for Alcohol Use Disorder.
Right now, there are only a few medications approved by the Food & Drug Administration (FDA) to treat Alcohol Use Disorder (AUD). A new medication that may help with AUD is called brexpiprazole (BREX). It is already approved by the FDA to treat schizophrenia and depression, but it is not approved to treat AUD. The results of this study may help us learn whether BREX can be a new treatment option for AUD. In this study, we will look at two different doses of BREX compared to a placebo, which is a pill that looks like the medicine but has no medical effect on you. We will also study whether your genetics might play a role in how the medication works. First, we will check to see if you qualify for the study. You will be asked questions about yourself and your life. You will also get a blood test and a urine test. You will also have a saliva or breath alcohol test to check your breath alcohol. We will check your height, weight, blood pressure, heart rate, and breathing. If you qualify for the study, you will be randomly placed into one of three groups, kind of like flipping a coin. Along with some of the tests you already took, you will also get functional magnetic resonance imaging (fMRI) scans. This scan helps us see how brexpiprazole affects brain activity. You will have 7 visits. You will be in the study for 2 weeks. You do not have to pay to be in the study. You can earn up to $650 if you complete all the visits.
You may be able to join the study if you are between 21 and 65 years old and are not currently looking for treatment for AUD.
Protocol Number: 19-1658
More information available at ClinicalTrials.gov: NCT04066192
Principal Investigator