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Trial registered on ANZCTR


Registration number
ACTRN12609000649213
Ethics application status
Not yet submitted
Date submitted
30/07/2009
Date registered
31/07/2009
Date last updated
31/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A placebo-controlled, randomized clinical trial of Bioeffective A in the management of acute alcohol withdrawal and alcohol abstinence maintenance
Scientific title
A placebo-controlled, randomized clinical trial of Bioeffective A in the management of acute alcohol withdrawal and alcohol abstinence maintenance in alcohol dependent patients admitted to a community-based residential withdrawal unit.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alcohol withdrawal 237297 0
alcohol dependence 237298 0
Condition category
Condition code
Mental Health 239621 239621 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients entered into the trial will be randomized to receive either Bioeffective A 320mg three times daily (1 capsule three times daily) or placebo 1 capsule three times daily for the full 12 weeks duration of the trial. The trial will examine the effect of Bioeffective A versus placebo during two phases of treatment; Phase 1: acute alcohol withdrawal (defined as the first 7 days following cessation of alcohol intake), and Phase 2: the subsequent 11 weeks of alcohol abstinence maintenance. During Phase 1 (acute alcohol withdrawal) the trial will examine the effect of Bioeffective A versus placebo on the outcome of conventional treatment of alcohol withdrawal in 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. Phase 2 of the trial will examine the effect of Bioeffective A versus placebo on the outcome of conventional treatment of alcohol abstinence maintenance, during which all subjects will receive supportive counselling during attendance at a regular schedule of outpatient clinic reviews.
Intervention code [1] 236979 0
Treatment: Drugs
Comparator / control treatment
placebo
Control group
Placebo

Outcomes
Primary outcome [1] 238410 0
Phase 1 (acute alcohol withdrawal): Number (%) of patients in each treatment arm requiring administration of diazepam or another benzodiazepine over initial 7 days of hospital admission, as assessed from the patients' inpatient medical and pharmacy records.
Timepoint [1] 238410 0
Assessed at the end of the initial 7 days of hospital admission.
Primary outcome [2] 238411 0
Phase 2 (alcohol abstinence maintenance): Percentage of heavy drinking days, defined as days with 5 or more standard drinks for men and 4 or more standard drinks for women, assessed by timeline follow back method.
Timepoint [2] 238411 0
Weekly for 5 weeks following the initial 7 days of alcohol withdrawal, then second weekly for 6 weeks
Secondary outcome [1] 244886 0
Phase 1 (acute alcohol withdrawal): Total dose of diazepam or benzodiazepine equivalent administered over the first 7 days of hospital admission, as assessed from the patients' inpatient medical and pharmacy records.
Timepoint [1] 244886 0
Assessed at the end of the initial 7 days of hospital adminssion.
Secondary outcome [2] 244887 0
Phase 1 (acute alcohol withdrawal): 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 7 days of hospital admission.
Timepoint [2] 244887 0
Assessed at the end of the initial 7 days of hospital adminssion.
Secondary outcome [3] 244888 0
Phase 2 (alcohol abstinence maintenance): Amount of drinking, measured as drinks per day and drinks per heavy drinking day and assessed by timeline follow back method.
Timepoint [3] 244888 0
Weekly for 5 weeks following the initial 7 days of alcohol withdrawal, then second weekly for 6 weeks.
Secondary outcome [4] 244889 0
Phase 2 (alcohol abstinence maintenance): Relapse: time to first relapse into heavy drinking and time to first drink, assessed by timeline follow back method.
Timepoint [4] 244889 0
Weekly for 5 weeks following the initial 7 days of alcohol withdrawal, then second weekly for 6 weeks.
Secondary outcome [5] 244890 0
Phase 2 (alcohol abstinence maintenance): Abstinence: cumulative abstinence duration; percentage of abstinent days; percentage of complete abstinence, assessed by timeline follow back method.
Timepoint [5] 244890 0
Weekly for 5 weeks following the initial 7 days of alcohol withdrawal, then second weekly for 6 weeks.

Eligibility
Key inclusion criteria
Both male and female patients admitted to a community-based, residential inpatient treatment unit requesting alcohol withdrawal and ongoing alcohol abstinence maintenance, 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 Bioeffective A, already receiving Bioeffective A, previous treatment for alcohol withdrawal or abstinence maintenance within the past 28 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 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237362 0
Hospital
Name [1] 237362 0
Department of Addiction Medicine, St Vincent's Hospital, Melbourne
Country [1] 237362 0
Australia
Primary sponsor type
Individual
Name
Professor Jon Currie
Address
Department of Addiction Medicine, St Vincent's Hospital, Melbourne,
38 Fitzroy Street, Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 236857 0
Hospital
Name [1] 236857 0
St Vincent's Hospital, Melbourne
Address [1] 236857 0
Department of Addiction Medicine, St Vincent's Hospital, Melbourne,
38 Fitzroy Street, Fitzroy, Victoria 3065
Country [1] 236857 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239490 0
St Vincent's Hospital, Melbourne
Ethics committee address [1] 239490 0
Ethics committee country [1] 239490 0
Australia
Date submitted for ethics approval [1] 239490 0
14/08/2009
Approval date [1] 239490 0
Ethics approval number [1] 239490 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29928 0
Address 29928 0
Country 29928 0
Phone 29928 0
Fax 29928 0
Email 29928 0
Contact person for public queries
Name 13175 0
Professor Jon Currie
Address 13175 0
St Vincent's Hospital, Melbourne
PO Box 2900 Fitzroy
38 Fitzroy Street Fitzroy VIC 3065
Country 13175 0
Australia
Phone 13175 0
+61 3 92883467
Fax 13175 0
Email 13175 0
jon.currie@svhm.org.au
Contact person for scientific queries
Name 4103 0
Professor Jon Currie
Address 4103 0
St Vincent's Hospital, Melbourne
PO Box 2900 Fitzroy
38 Fitzroy Street Fitzroy VIC 3065
Country 4103 0
Australia
Phone 4103 0
+61 3 92883467
Fax 4103 0
Email 4103 0
jon.currie@svhm.org.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.