The Effects of Levetiracetam on Alcohol Dependent Subjects
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with
      alcohol dependence cut down on their alcohol consumption. In addition, the investigation will
      assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation.
      Matched group of historical controls of alcohol dependent patients receiving placebo will be
      used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be
      effective in promoting abstinence and reducing drinking behavior in alcohol dependent
      patients.
    

Detailed description: 
      Alcoholism is a chronic disease with numerous psychological, social and medical consequences.
      Alcohol use disorders are one of the most prevalent psychiatric disorders in general
      population in the US. Alcoholism not only disrupts an individual's life, health and ability
      to function in the society, has tremendous impact on families and communities, but also is
      associated with enormous economic cost for society. The medical and social impact of
      alcoholism can be reduced via effective treatments. Although medical, psychological and
      social approaches have demonstrated some efficacy, no specific method has consistently shown
      superiority. Similarly, currently available pharmacological treatments for alcohol use
      disorders are associated with moderate efficacy, indicating that further efforts are required
      to develop novel interventions.

      The rewarding effects of alcohol are at least partially mediated via dopamine pathways that
      originate in the ventral tegmental area and project to the nucleus accumbens. Alcohol through
      its effects on GABA receptor activity decreases the inhibitory effect of GABA on the
      dopaminergic neurons in ventral tegmental area and therefore facilitates dopamine
      neurotransmission. Medications that modulate excitatory neurotransmission in the brain
      (glutamate) and facilitate inhibitory effects of GABA have been shown to be clinically
      effective in treatment of alcoholism.

      Keppra is a novel antiepileptic medication currently approved for treatment of partial onset
      seizures as an adjunctive agent. It has a unique mechanism of action in that it reduces
      negative allosteric effects of Zn++ and Beta- carboline in two main inhibitory receptors in
      the CNS- the GABA A and glycine receptors. These modulators inhibit the influx of chloride
      though both of these receptor complexes and are therefore considered excitatory mediators.
      Keppra prevents the negative modulation and promotes chloride flux, thereby, inhibiting
      neurotransmission.

      Limited laboratory work with levetiracetam (Keppra) has shown that the medication can reverse
      the anxiogenic effect of benzodiazepine withdrawal in mice (Y. Lamberty et al., 2002).
      Furthermore, Keppra was investigated for its potential to prevent alcohol withdrawal symptoms
      in mice. In this study levetiracetam dose-dependently prevented spontaneous tremors and
      handling induced convulsions in alcohol dependent mice. (Y. Lamberty et al., 2002). Based on
      the mechanism of action of Keppra we hypothesize that it may be effective in promoting
      abstinence and reducing drinking behavior in alcohol dependent patients.
    

Intervention name(s): Levetiracetam; Historical controls
Intervention type(s): Drug; Other
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcoholism