Titre : | A randomized, placebo-controlled study of high-dose baclofen in alcohol-dependent patients - The ALPADIR Study (2017) |
Auteurs : | M. REYNAUD ; H. J. AUBIN ; F. TRINQUET ; B. ZAKINE ; C. DANO ; M. DEMATTEIS ; B. TROJAK ; F. PAILLE ; M. DETILLEUX |
Type de document : | Article : Périodique |
Dans : | Alcohol and Alcoholism (Vol.52, n°4, July 2017) |
Article en page(s) : | 439-446 |
Langues: | Anglais |
Discipline : | TRA (Traitement et prise en charge / Treatment and care) |
Mots-clés : |
Thésaurus géographique FRANCEThésaurus mots-clés ALCOOL ; ALCOOLIQUE ; BACLOFENE ; ETUDE RANDOMISEE ; PHARMACOTHERAPIE ; ABSTINENCE ; ETUDE CLINIQUE ; TRAITEMENT ; REDUCTION DE CONSOMMATION ; COMPULSION ; EFFET SECONDAIRE |
Résumé : |
Aims: Alcohol dependence is a major public health issue with a need for new pharmacological treatments. The ALPADIR study assessed the efficacy and safety of baclofen at the target dose of 180 mg/day for the maintenance of abstinence and the reduction in alcohol consumption in alcohol-dependent patients.
Methods: Three hundred and twenty adult patients (158 baclofen and 162 placebo) were randomized after alcohol detoxification. After a 7-week titration, the maintenance dose was provided for 17 weeks, then progressively decreased over 2 weeks before stopping. Results: The percentage of abstinent patients during 20 consecutive weeks (primary endpoint) was low (baclofen: 11.9%; placebo: 10.5%) and not significantly different between groups (OR 1.20; 95%CI: 0.58 to 2.50; P = 0.618). A reduction in alcohol consumption was observed from month 1 in both groups, but the difference of 10.9 g/day at month 6 between groups, in favour of baclofen, was not statistically significant (P = 0.095). In a subgroup of patients with high drinking risk level at baseline, the reduction was greater with a difference at month 6 of 15.6 g/day between groups in favour of baclofen (P = 0.089). The craving assessed with Obsessive-Compulsive Drinking Scale significantly decreased in the baclofen group (P = 0.017). No major safety concern was observed. Conclusions: This study did not demonstrate the superiority of baclofen in the maintenance of abstinence at the target dose of 180 mg/day. A tendency towards a reduction in alcohol consumption and a significantly decreased craving were observed in favour of baclofen. Short summary: Baclofen was assessed versus placebo for maintenance of abstinence and reduction in alcohol consumption in alcohol-dependent patients. This study did not demonstrate the superiority of baclofen in the maintenance of abstinence. A tendency towards a reduction in alcohol consumption and a significantly decreased craving were observed in favour of baclofen. |
Domaine : | Alcool / Alcohol |
Affiliation : | Actions Addictions-Saint Joseph Hospital, Paris, France |
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