...Baclofen has been proven effacious in several studies including a double-blind random controlled trial:
High-dose baclofen for the treatment of alcohol dependence (BACLAD study): a randomized, placebo-controlled trial.
M?_ller CA1, Geisel O2, Pelz P2, Higl V2, Kr?_ger J2, Stickel A2, Beck A2, Wernecke KD3, Hellweg R2, Heinz A2.
Abstract
Previous randomized, placebo-controlled trials (RCTs) assessing the efficacy of the selective γ-aminobutyric acid (GABA)-B receptor agonist baclofen in the treatment of alcohol dependence have reported divergent results, possibly related to the low to medium dosages of baclofen used in these studies (30-80mg/d). Based on preclinical observations of a dose-dependent effect and positive case reports in alcohol-dependent patients, the present RCT aimed to assess the efficacy and safety of individually titrated high-dose baclofen for the treatment of alcohol dependence. Out of 93 alcohol-dependent patients initially screened, 56 were randomly assigned to a double-blind treatment with individually titrated baclofen or placebo using dosages of 30-270mg/d. The multiple primary outcome measures were (1) total abstinence and (2) cumulative abstinence duration during a 12-week high-dose phase.
More patients of the baclofen group maintained total abstinence during the high-dose phase than those receiving placebo (15/22, 68.2% vs. 5/21, 23.8%, p=0.014). Cumulative abstinence duration was significantly higher in patients given baclofen compared to patients of the placebo group (mean 67.8 (SD 30) vs. 51.8 (SD 29.6) days, p=0.047). No drug-related serious adverse events were observed during the trial. Individually titrated high-dose baclofen effectively supported alcohol-dependent patients in maintaining alcohol abstinence and showed a high tolerability, even in the event of relapse. These results provide further evidence for the potential of baclofen, thereby possibly extending the current pharmacological treatment options in alcohol dependence.
Suppression of alcohol dependence using baclofen: a 2-year observational study of 100 patients.
de Beaurepaire R1.
Abstract
AIMS:
The purpose of this study was to examine the long-term effects of baclofen in a large cohort of alcohol-dependent patients compliant to baclofen treatment.
METHODS:
A hundred patients with alcohol dependence, resistant to usual treatments, were treated with escalating doses of baclofen (no superior limit). Alcohol consumption (in grams) and craving for alcohol were assessed before treatment and at 3, 6, 12, and 24 months. Assessments were simply based on patients' statements. The outcome measure was the consumption of alcohol, rated according to the World Health Organization criteria for risk of chronic harm.
RESULTS:
While all patients were rated "at high risk" at baseline, approximately half of them were rated "at low risk" at 3, 6, 12, and 24 months. The sum of patients who were at "low risk" and at "moderate risk" (improved patients) was 84% at 3 months, 70% at 6 months, 63% at 1 year, and 62% at 2 years. The constancy of improvement over the 2-years was remarkable. The average maximal dose of baclofen taken was 147 mg/day. Ninety-two percentage of patients reported that they experienced the craving-suppressing effect of baclofen. Significant relationships were found between the amount in grams of alcohol taken before treatment and the maximal dose of baclofen required, and between the existence of a mental disorder and a lesser effect of baclofen.
CONCLUSION:
Baclofen produces an effortless decrease or suppression of alcohol craving when it is prescribed with no superior limit of dose. Potential limitations in the effectiveness of baclofen include the coexistence of a mental disorder, the concomitant use of other psychotropic drugs, a lack of real motivation in patients to stop drinking, and the impossibility to reach the optimal dose of baclofen because of unbearable side-effects (sometimes possibly related to too sharp a protocol of dose escalation).
Abstinence and 'low-risk' consumption 1 year after the initiation of high-dose baclofen: a retrospective study among 'high-risk' drinkers.
Rigal L1, Alexandre-Dubroeucq C, de Beaurepaire R, Le Jeunne C, Jaury P.
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.
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