Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to learn about the use of a combination of two
medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and
women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of alcohol
dependence. The most widely accepted idea for naltrexone's effect is that it reduces the
alcohol "high", which decreases a desire to consume alcohol. As a result, alcoholic patients
treated with naltrexone are less likely to relapse to heavy drinking. Furthermore, naltrexone
treated patients drink fewer days and are more likely to maintain abstinence.
However, naltrexone does not have any effect on other symptoms that may contribute to relapse
such as anxiety, sleep problems and irritability. Baclofen, an FDA approved medication for
muscle spasms, may improve some of these symptoms.
Therefore, the purpose of the current study is to gather information on whether adding
baclofen to naltrexone is feasible and well tolerated.