Michel Reynaud1, Henri-Jean Aubin2, Francoise Trinquet3, Benjamin Zakine3, Corinne Dano4, Maurice Dematteis5, Benoit Trojak6, Francois Paille7, Michel Detilleux8. 1. Actions Addictions-Saint Joseph Hospital, 185 rue Raymond Losserand, 75014 Paris, France. 2. Department of Addiction Medicine, University Hospital Paris Sud, Villejuif, France. 3. Medical department, Ethypharm SAS, Saint Cloud, France. 4. Department of Addiction Medicine, University Hospital, Angers, France. 5. Department of Addiction Medicine, Grenoble Alpes University Hospital, Grenoble, France. 6. Department of Psychiatry/Addictology, University Hospital, Dijon, France. 7. Department of Addictology, Brabois Hospital, Vandoeuvre, France. 8. Department of Internal Medicine, Paris Cochin Hospital, Paris Descartes University, France.
Abstract
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.
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.
Authors: Warren B Logge; Richard W Morris; Andrew J Baillie; Paul S Haber; Kirsten C Morley Journal: Psychopharmacology (Berl) Date: 2019-02-20 Impact factor: 4.530
Authors: Jia W Romito; Emily R Turner; John A Rosener; Landon Coldiron; Ashutosh Udipi; Linsey Nohrn; Jacob Tausiani; Bryan T Romito Journal: SAGE Open Med Date: 2021-06-03