Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000362493
Ethics application status
Not yet submitted
Date submitted
4/07/2007
Date registered
6/07/2007
Date last updated
6/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A placebo-controlled, randomized clinical trial of vigabatrin in the management of acute alcohol withdrawal
Scientific title
A placebo-controlled, randomized clinical trial of vigabatrin in the management of acute alcohol withdrawal
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alcohol withdrawal 1920 0
Condition category
Condition code
Mental Health 2012 2012 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1872 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2840 0
Number (%) of patients in each treatment arm requiring administration of diazepam or another benzodiazepine over initial 3 days of hospital admission
Timepoint [1] 2840 0
Assessed at the end of the initial 3 days of hospital admission.
Primary outcome [2] 2862 0
Number (%) of patients in each treatment arm requiring administration of diazepam or another benzodiazepine over initial 3 days of hospital admission.
Timepoint [2] 2862 0
Assessed at the end of the initial 3 days of hospital admission.
Secondary outcome [1] 4785 0
Total dose of diazepam or benzodiazepine equivalent administered over the first three days of hospital admission.
Timepoint [1] 4785 0
Assessed at the end of the initial 3 days of hospital adminssion.
Secondary outcome [2] 4786 0
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.
Timepoint [2] 4786 0
Assessed at the end of the initial 3 days of hospital adminssion.
Secondary outcome [3] 4824 0
Total dose of diazepam or benzodiazepine equivalent administered over the first three days of hospital admission
Timepoint [3] 4824 0
Assessed at the end of the initial 3 days of hospital adminssion.
Secondary outcome [4] 4825 0
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
Timepoint [4] 4825 0
Assessed at the end of the initial 3 days of hospital adminssion.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment numbered containers, off-site allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All of the following will be blinded as to active or placebo treatment. The people receiving the treatment (subjects), the people administering the treatment (clinicians), the people assessing the outcomes (assessors) and the people analysing the results/data (data analysts) up to the time that the randomisation code is broken/revealed.
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2154 0
Hospital
Name [1] 2154 0
Department of Addiction Medicine, St Vincent's Hospital, Melbourne
Country [1] 2154 0
Australia
Funding source category [2] 2178 0
Hospital
Name [2] 2178 0
Department of Addiction Medicine, St Vincent's Hospital
Country [2] 2178 0
Australia
Primary sponsor type
Individual
Name
Professor Jon Currie
Address
Country
Secondary sponsor category [1] 1966 0
Hospital
Name [1] 1966 0
St Vincent's Hospital, Melbourne
Address [1] 1966 0
Country [1] 1966 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3948 0
St Vincent's Hospital
Ethics committee address [1] 3948 0
Melbourne
Ethics committee country [1] 3948 0
Australia
Date submitted for ethics approval [1] 3948 0
Approval date [1] 3948 0
Ethics approval number [1] 3948 0
Ethics committee name [2] 3975 0
St Vincent's Hospital
Ethics committee address [2] 3975 0
Melbourne
Ethics committee country [2] 3975 0
Australia
Date submitted for ethics approval [2] 3975 0
Approval date [2] 3975 0
Ethics approval number [2] 3975 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27686 0
Address 27686 0
Country 27686 0
Phone 27686 0
Fax 27686 0
Email 27686 0
Contact person for public queries
Name 11061 0
Professor Jon Currie
Address 11061 0
St Vincent's Health Melbourne
PO Box 2900
38 Fitzroy Street
Fitzroy VIC 3065
Country 11061 0
Australia
Phone 11061 0
+61 3 92883467
Fax 11061 0
Email 11061 0
[email protected]
Contact person for scientific queries
Name 1989 0
Professor Jon Currie
Address 1989 0
St Vincent's Health Melbourne
PO Box 2900
38 Fitzroy Street
Fitzroy VIC 3065
Country 1989 0
Australia
Phone 1989 0
+61 3 92883467
Fax 1989 0
Email 1989 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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