UNC Study of Bupropion with Naltrexone for Binge Drinking
(UNC IRB# 16-1370)
Investigation of Cortical Adaptation to Tactile Sensory Stimulation Combined with an Open Label Trial of Bupropion and Naltrexone
About the Study
The University of North Carolina at Chapel Hill is seeking volunteers for a research study testing whether the combination of bupropion and naltrexone, both FDA approved medications, can help reduce binge drinking episodes. Bupropion is currently used to treat depression, but recently, studies have suggested that bupropion might be helpful when used in conjunction with naltrexone in the treatment of binge drinking. Naltrexone is FDA approved to treat alcohol abuse and dependence.
The study is an open label pilot study, meaning everyone who enrolls receives the same medication.
Who is eligible?
We are looking for volunteers who are experiencing any of the following:
- Regularly drinking alcohol in binges (4 or more drinks in under 2 hours)
- Have tried to cut back on alcohol use but can't
- Are noticing that their alcohol use is creating problems
- Feel they have a problem with drinking
Additionally, to qualify, you should be:
- Between the ages of 21 and 34
- Able to read and fill out questionnaires in English
- Ready to stop drinking completely or greatly reduce your alcohol consumption
You may not qualify if you are:
- Physically dependent on alcohol
- Currently pregnant or breastfeeding
- Suffering from an unstable medical disease that might present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, diabetes, or seizure disorder)
- Currently experiencing severe depression or having suicidal thoughts
- Diagnosed with Schizophrenia or you have been hospitalized for mania or bipolar disorder
- Addicted to or abusing other substances (Some occasional use may be acceptable)
- Currently taking Valium, Xanax, Librium, Clonazepam, Ritalin, Risperdal, Seroquel, Ablilify, Lithium, Naltrexone, Vivitrol, Campral, Antabuse, IV methylene blue, the antibiotic lineaolid, or MAO inhibitors.
- Court mandated to seek treatment for your alcohol use
What is involved?
- Phone Screening: Initially, if you are interested in our study, you should contact the study staff to set up a time for a phone screen. Study Staff will review the study information with you, answer any questions you may have, then, ask you a few preliminary questions to see if you appear to qualify for the study. If you do and you wish to continue you will be invited for a screening visit.
- Screening Visit: The screening visit takes approximately 2-3 hours. At this visit, we will ask you questions and give you questionnaires about your general health, your mental health, your drinking behavior, your use of street drugs and your family history. We will do a brief physical exam and draw blood and urine. We will also conduct sensory testing in which you will respond on a computer to slight vibrations on your fingertips.
We will use the information gathered on Screening Day to determine if you are eligible for the study. If you are eligible we will contact you and schedule you to come in for a follow up visit where you will receive your study medication, usually within 1-2 weeks of screening.
- Follow-Up Visits: Over the course of next 3 months, you will participate in 6 follow visits which last about an hour each. At all the visits we will obtain a Breathalyzer reading, check your blood pressure, and ask you to complete questionnaires about your general health, mental health, your drinking behavior. At your first visit, you will be asked to take a Sweet Liking test in which you will taste 5 sugar-water mixtures and rate how sweet and pleasurable they are. Blood and urine will be collected at 3 visits to measure your general health. You will also meet with a counselor at each follow up visit to discuss progress toward meeting your drinking goals.
- Additional Information: All visits take place at the UNC Neurosciences Hospital in Chapel Hill, Carolina Crossing at 2218 Nelson Highway in Chapel Hill, or the NC Psychiatry Research Center in Raleigh. This is an open label study, meaning that everyone who enrolls will be on the same medication.
You are given parking vouchers at each visit so you do not need to pay for parking. Additionally, you can receive up to $185 depending on your level of participation.
For additional information or to set up a phone screening
Call 919-966-0011 or fill out the online pre-screen.