The study is a clinical research study evaluating the effects of a drug called pitolisant (also known as Wakix) on alcohol craving and consumption. This medication has been approved by the Food and Drug Administration (FDA) for treatment of excessive daytime sleepiness in people with narcolepsy. It has no known use in the treatment of alcohol related problems, but we believe that this medication could help people to reduce craving and consumption. We are conducting this study to see if taking pitolisant for 12 days will have an impact on alcohol craving and alcohol consumption. The most commonly reported side effects of pitolisant are headache, insomnia, and nausea.

To take part in this study, you must be between the ages of 21 and 55 and have a state or federal picture ID with proof of your age. You must also own a smartphone with internet access in order to complete online surveys while taking the study medication.

Participants in this study will be asked to come in for 5-6 visits over a period of 58 days. The first visit is a screening visit. During this visit, you will be asked about your drug and alcohol history as well as your medical history. You will have a physical exam, blood and urine testing, and an electrocardiogram. This screening visit can be completed in a single in-person visit or you can come in twice to complete the screening. You may also complete part of the visit on a video call from home prior to coming into the clinic.

If you are eligible after your screening visit, you will come into the clinic to receive a 12-day supply of the pitolisant or a placebo. A placebo is a pill that has no active ingredients but looks just like the pitolisant pills.

After taking the study medication for 11 days, you will return to the clinic on day 12 for a 5-8 hour visit in which you will be asked to drink up to 9 alcoholic beverages over a period of three hours. It is required that you drink the first beverage and it will be your choice as to how many of the other drinks you will consume. During the third visit you will complete brief surveys while you drink. You will also have access to streaming entertainment including HBOgo, Netflix, and Youtube. You will be asked to not drive to this appointment and you will be required to stay until your blood alcohol level is below .04.

After the third visit, you will be asked to return to the clinic 7-10 days later to receive a second supply of study medication or placebo. After taking the medication again for 12 days, you will return to the clinic to repeat the drinking session visit a second time.

If you qualify for the study, the maximum total you may receive for completing all study requirements is $543. At each visit, we will ask you for a urine sample to test for recreational drugs. If you test positive for any drugs other than marijuana, you will be excluded from this study and will not be reimbursed.

All study is provided at no cost.