Not Yet RecruitingPhase 3ACTRN12607000362493

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


Sponsor

Professor Jon Currie

Enrollment

120 participants

Start Date

Sep 3, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates a placebo-controlled, randomized clinical trial of vigabatrin in the management of acute alcohol withdrawal. It is looking for both men and women, aged 18 and older who have patients admitted to either residential treatment unit for alcohol withdrawal or both male and female patients attending emergency department who h.... People who are pregnant or breastfeeding individuals cannot take part. If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 da

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


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ACTRN12607000362493


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