Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.

      Baclofen has been studied for alcoholism in Italy in 45 individuals in two studies. In the
      two Italian studies, baclofen significantly reduced alcohol withdrawal symptoms and craving
      for alcohol, as well as the use of alcohol. These data have been supported by the results of
      our own pilot study conducted here at UNC in 12 subjects with alcohol dependence. That study
      showed that baclofen was generally well tolerated, and some individuals had significant
      improvements in their drinking. Furthermore, we have recently completed enrolling 80 alcohol
      dependent patients into a placebo-controlled study of baclofen and are currently analyzing
      the data.

      Therefore, the purpose of the current study is to gather information on whether adding
      baclofen to naltrexone is feasible and well tolerated.
    

Intervention name(s): Naltrexone, Baclofen, Placebo and Behavior Therapy
Intervention type(s): Drug
Intervention description(s): Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
Other intervention name(s): Naltrexone/ ReVia
Intervention MeSH terms: Naltrexone; Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Alcohol; Alcohol Abuse; Alcohol Drinking