A placebo-controlled, randomized clinical trial of vigabatrin in the management of acute alcohol withdrawal

INTERVENTION: Patients entered into the trial will be randomized to receive either vigabatrin 500mg x 4 tablets (=2 gram total per dose) statim, and then vigabatrin 500mg x 4 tablets (=2 gram) each morning for 3 days, or placebo 4 tablets statim and then 4 tablets each morning for 3 days. The trial will examine the effect of vigabatrin versus placebo on the outcome of conventional treatment of alcohol withdrawal which all subjects will receive benzodiazepines prescribed as needed according to the severity of alcohol withdrawal as measured by the Clinical Institute Withdrawal Assessment for Alcohol ‐ revised (CIWA‐Ar) alcohol withdrawal scale CONDITION: alcohol withdrawal PRIMARY OUTCOME: Number (%) of patients in each treatment arm requiring administration of diazepam or another benzodiazepine over initial 3 days of hospital admission Number (%) of patients in each treatment arm requiring administration of diazepam or another benzodiazepine over initial 3 days of hospital admission. SECONDARY OUTCOME: Intensity and duration of alcohol withdrawal as measured by area under curve from Clinical Institute Withdrawal Assessment for Alcohol ‐ revised (CIWA‐Ar) alcohol withdrawal scale for the first three days of hospital admission Intensity and duration of alcohol withdrawal as measured by area under curve from Clinical Institute Withdrawal Assessment for Alcohol ‐ revised (CIWA‐Ar) alcohol withdrawal scale for the first three days of hospital admission. Total dose of diazepam or benzodiazepine equivalent administered over the first three days of hospital admission Total dose of diazepam or benzodiazepine equivalent administered over the first three days of hospital admission. ; INCLUSION CRITERIA: Patients admitted to either residential treatment unit for alcohol withdrawal or both male and female patients attending emergency department who have alcohol intake of 6 or more drinks per day over at least the past 3 months.