A Retrospective Study of High-Dose Baclofen for High-Risk Drinking Supports the Need for a Randomized Controlled Trial

Baclofen, a GABA agonist, is being tested as a potential candidate to treat alcohol dependence. Randomized trials of low-dose baclofen (30 mg per day) have had mixed results. The use of high-dose baclofen has not been studied in randomized trials, but positive results were found in a few case reports. In this study, 2 physicians examined 12-month outcomes in 181 patients with high-risk alcohol use (81% with dependence) to whom they had prescribed high-dose baclofen (mean maximum dose, 145 mg per day). One hundred thirty-two patients were available for follow-up. At 1 year,

• 43% of the original 181 patients reported abstinence, and 15% reported low-risk* drinking.

• among those available for follow-up (73%),
  

   

  • 83% were still taking high-dose baclofen.
  • 86% reported adverse effects (somnolence, insomnia, vertigo, digestive disorders, and/or confusion).
  • the proportion of psychiatric disorders was significantly lower among those with abstinence and low-risk drinking compared with those consuming higher amounts (15% versus 88%, respectively).

Comments:

Although results of this retrospective case series are promising, it is not possible to separate effects of the drug from effects of other things that happened during treatment (such as medical management, regular appointments, and life events). Also, bias may have influenced the results (selection of patients and/or doctors who believe in the treatment, for example). The possible benefits identified in this case series and other case reports justify conducting a randomized controlled trial to investigate the efficacy and safety of high-dose baclofen.

Nicolas Bertholet, MD, MSc

Reference:

Rigal L, Alexandre-Dubroeucq C, de Beaurepaire R, et al. Abstinence and ‘low-risk’ consumption 1 year after the initiation of high-dose baclofen: a retrospective study among ‘high-risk’ drinkers. Alcohol Alcohol. 2012;47(4):439–442.