Clinical effectiveness of baclofen for the treatment of alcohol dependence: a review

Jessica L Brennan,² Jonathan G Leung,¹ Jane P Gagliardi,³ Sarah K Rivelli,³ Andrew J Muzyk<sup>4

1</sup>Department of Hospital Pharmacy Services, Mayo Clinic, Rochester, MN, ²Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, PA, ³Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, ⁴Department of Pharmacy Practice, Campbell University School of Pharmacy and Health Sciences, Buies Creek, NC, USA

Abstract: Baclofen, an agonist at the B subunit of gaba-aminobutyric acid receptor, possesses pharmacologic properties that may confer utility for the treatment of alcohol dependence. Research suggests that not only can it be useful in promoting maintenance of alcohol abstinence but also it may play a key role in decreasing alcohol cravings and anxiety often associated with alcohol dependence. To assess the benefit of baclofen for alcohol dependence, a review of the literature was conducted to identify published data investigating this off-label treatment. Four randomized controlled trials to date have been published and were included in this review. Although primary outcomes differ between studies, patients randomized to baclofen experience higher rates of abstinence from alcohol than those taking placebo in two of the trials. Secondary analyses indicate that baclofen is safe in patients with alcohol dependence, including those with moderate to severe liver cirrhosis, and may provide beneficial anxiolytic effects. Despite some positive data, the largest available randomized controlled trial failed to find any differences between baclofen and placebo. In all studies, individuals with severe medical comorbidities, seizure disorders, and psychiatric disorders were excluded from trials, which may limit external validity. In summary, there may be beneficial effects from using baclofen for the treatment of alcohol dependence; however, limited conclusions can be drawn from the small number of studies currently available for review. Larger well-designed trials are needed to further define baclofen's role for the treatment of alcohol dependence.

Keywords: baclofen, alcohol, abstinence, relapse, craving, dependence