None listed
Conditions
Brief summary
The purpose of this project is to assess a new treatment for alcohol withdrawal in patients who are admitted to hospital. Alcohol withdrawal can be a severe condition. Usually it is treated with benzodiazepines such as diazepam, but these medications can have dangerous side-effects such as excessive sedation and depression of respiration. The new treatment uses a medication called vigabatrin. Vigabatrin is usually used for treating epilepsy, but it has been found in preliminary studies to also be useful in treating alcohol withdrawal because it reduces the severity of alcohol withdrawal symptoms, shortens the duration of alcohol withdrawal and may also prevent alcohol withdrawal seizures, without causing sedation or depressing respiration.
Interventions
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
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
Sponsors
Professor Jon Currie
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Inability to take oral medication.pregnancy or breast feeding.known allergy to vigabatrin.already receiving vigabatrin.previous treatment for alcohol withdrawal within the past 7 days.
Outcome results
None listed