Abstinence 1 Year After the Initiation of High-Dose Baclofen
Abstinence 1 Year After the Initiation of High-Dose Baclofen
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.
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.
Abstract and Introduction
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.
