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

Phase 3

• Conditions: alcohol withdrawal; Mental Health - Addiction

• Registration Number: ACTRN12607000362493
• Lead Sponsor: Professor Jon Currie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber (%) of patients in each treatment arm requiring administration of diazepam or another benzodiazepine over initial 3 days of hospital admission[Assessed at the end of the 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.[Assessed at the end of the initial 3 days of hospital admission.]

Secondary Outcome Measures

Name	Time	Method
Total dose of diazepam or benzodiazepine equivalent administered over the first three days of hospital admission. <br>[Assessed at the end of the initial 3 days of hospital adminssion.];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. [Assessed at the end of the initial 3 days of hospital adminssion.];Total dose of diazepam or benzodiazepine equivalent administered over the first three days of hospital admission[Assessed at the end of the initial 3 days of hospital adminssion.];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[Assessed at the end of the initial 3 days of hospital adminssion.]