Background: 6-month naturalistic, open-label trial to compare amisulpride versus topiramate and naltrexone as a treatment for patients with alcohol dependence, with assessments at enrolment and after 3 and 6 months of treatment.
Methods: 274 alcohol-dependent patients who had been drinking heavily during the past month were included. Once detoxified, patients were assigned to one of three treatment groups (naltrexone 50 mgr per day, topiramate 200 mgr per day or amisulpride 100 mgr per day). Patients were assessed at baseline and after 3 and 6 months of follow-up. Outcome was measured using tools that assessed alcohol intake (EuropASI and Alcohol Timeline Followback), craving (OCDS), disability (WHO/DAS), and quality of life (EQ-5D); changes in biomarkers of alcohol intake were also noted.
Results: at the 6-month follow-up patients taking amisulpride had poorer results than those taking topiramate in direct measures of alcohol intake (OCDS, alcohol intake, number of drinks per day and heavy drinking days), but no significant differences were found in these measures on comparing the amisulpride patients with those taking naltrexone.
Conclusions: in this study, amisulpride, at a dose of 100 mgr per day, was less effective than topiramate, at a dose of 200 mg per day, but as effective as naltrexone, at a dose of 50 mg per day, for reducing alcohol intake and craving over the period of the study.