Abstinence and ‘Low-Risk’ Consumption 1 Year After the Initiation of High-Dose Baclofen

From Alcohol and Alcoholism

A Retrospective Study Among ‘High-Risk’ Drinkers

Laurent Rigal; Constance Alexandre-Dubroeucq; Renaud de Beaurepaire; Claire Le Jeunne; Philippe Jaury

Authors and Disclosures

Posted: 08/13/2012; Alcohol Alcohol. 2012;47(4):439-42. © 2012 Oxford University Press

Abstract

Aims: The aim of the study was to assess the proportions of ‘high-risk’ drinkers’ abstinent or with ‘low-risk’ consumption levels 1 year after the initiation of high-dose baclofen.
Methods: This is a retrospective ‘open’ study; the outcome of this study was to assess the level of alcohol consumption in the 12th month of treatment.
Results: Of the 181 patients included, a follow-up evaluation was possible in 132 patients. The initial alcohol consumption of the 132 patients analysed averaged 182 ± 92 g/day. After 1 year, 80% of the 132 (i.e. 58% of 181) were either abstinent (n = 78) or drinking at low-risk levels (n = 28) in their 12th month of treatment. The mean baclofen dose at 1 year was 129 ± 71 mg/day.
Conclusion: High-dose baclofen should be tested in randomized placebo-controlled trials among high-risk drinkers.

Introduction

Baclofen, a gamma-aminobutyric acid ‘B-receptor’ agonist, has long been used to treat spasticity from neurological diseases, at a dose of 30–90 mg/day. It appears today to be a promising but controversial candidate for treating alcoholic patients (Enserink, 2011), by reducing or even suppressing their craving (which we define here as an irrepressible sense of needing) to drink. A few case reports (Ameisen, 2005; Bucknam, 2007; Dore et al., 2011) suggest that some patients might respond favourably to baclofen at doses >90 mg/day. Although no randomized controlled trial testing such doses has yet been conducted, some physicians are prescribing high-dose baclofen off-label to informed patients in a compassionate approach. To date, published randomized controlled trials have tested 30 mg/day dosage (Addolorato et al., 2002, 2007; Garbutt et al., 2010).

This study presents two physicians’ clinical experience of prescribing high-dose baclofen in patients with ‘high-risk’ consumption levels, as defined by the World Health Organization (WHO; i.e. >40 g/day for women and >60 g/day for men; World Health Organization, 2000). As part of their usual clinical practice, they prescribed baclofen at a progressively increasing dose (steps of 15 mg/week, then 30 if possible, according to tolerance) until it abolished craving, to the extent possible, thereby allowing patients to reduce their consumption to the WHO’s ‘low-risk’ level (i.e. ≤20 g/day for women and ≤40 g/day for men; World Health Organization, 2000) or even become abstinent.

The aim of the study was to assess the proportions of ‘high-risk’ drinkers who had either one of the two satisfactory alcohol consumption profiles (full abstinence or ‘low-risk’ consumption) during the 12th month of high-dose baclofen treatment. Our secondary objectives were to examine the patient characteristics associated with these profiles and to analyse the tolerance for and safety of high doses of baclofen.