Background:
- Baclofen is a drug used to control muscle stiffness in people with neurological diseases.
Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce
anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if
baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.
Objectives:
- To see if baclofen is safe and helpful for people who have alcoholism and high anxiety
levels.
Eligibility:
- Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and
anxiety issues.
- Participants must not be taking anti-anxiety medication.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine
samples will be collected. Tests of alcohol dependency and anxiety levels will also be
given.
- Participants will be divided into two groups. One group will take baclofen. The other
group will have a placebo.
- About 1 week after the screening visit, participants will have a study visit. They will
answer questions about their behavior and mood. They will then start to take either
baclofen or a placebo. Participants will take the study drug three times a day, every
day.
- After 1 week on the study drug, participants will have an overnight stay at the National
Institutes of Health. They will have blood tests and answer questions about mood and
behavior. They will also have tests that involve choosing to drink alcohol and answering
more questions about cravings.
- Participants will stop taking their study drug over a 3-day period.
- A final follow-up visit will be required 1 week after the overnight study visit.
Participants will receive information about other alcohol abuse treatment programs.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)