drugset / Trial / NCT00614328

Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.

NCT00614328

Phase 1 Completed 40 enrolled University of North Carolina, Chapel Hill
RandomizedParallel-groupQuadruple-blindBasic science

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.

Timeline

Start
2007-07
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Baclofen Small molecule 10 mg
Comparator Naltrexone Small molecule 50 mg

Indications