The Safety and Efficacy of High Dose Baclofen for Alcohol Dependence
About the Study
The University of North Carolina at Chapel Hill is seeking volunteers for a research study testing whether baclofen, an FDA approved medication, can help reduce alcohol consumption. Baclofen is currently used to treat muscle spasticity, but recently, several studies have suggested that baclofen might be helpful for the treatment of alcohol dependence. The study will also examine the effect of baclofen on anxiety.
The study is a double-blind, placebo-controlled trial. This means that neither you nor the doctors will know whether you are taking baclofen or a placebo (sugar pill). Baclofen will be given at two doses—30 mg per day and 90 mg per day. (IRB # 12-1743)
Who is eligible?
We are looking for volunteers who are experiencing any of the following:
- Have tried to cut back on alcohol use but can't
- Have increased the amount of alcohol they drink
- 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 18 and 65
- 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:
- 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, or Antabuse
- Court mandated to seek treatment for your alcohol use
What is involved?
- Pre-Screening: Initially, if you are interested in our study, you can take the online pre-screen at the top of the page, or if you prefer, you can contact the study staff by phone (919-966-0011) or email (firstname.lastname@example.org) to complete it. Study Staff will review your prescreen information with you, answer any questions you may have, then, review your information with the study doctor. If the doctor thinks you may qualify for the study 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 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 4 months, you will participate in 11 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. Blood and urine will be collected at 4 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 UNC Hospitals, Carolina Crossing (Intersection of 54/40) or the NC Psychiatry Research Center in Raleigh. The study medication is taken 3 times a day. You will be randomly assigned to receive either placebo, 30 mg per day of baclofen or 90 mg per day of baclofen. Random assignment means that which group you join will be determined by chance, similar to flipping a coin. Neither you nor the doctors will know which group you are assigned. If an emergency arises the study doctors can find out what medication you are taking.
You are given parking vouchers and/or bus passes if needed. Additionally, you can receive up to $375 depending on your level of participation.
To take our online pre-screen to see if you may be eligible, please click here.
For additional information or to set up a phone screening
Call 919-966-0011 or Email Us