Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000513415
Ethics application status
Not yet submitted
Date submitted
4/10/2007
Date registered
9/10/2007
Date last updated
9/10/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of subcutaneous flumazenil infusion in the management of benzodiazepine dependence
Scientific title
Subcutaneous flumazenil infusion in the management of benzodiazepine dependence
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
benzodiazepine dependence 2423 0
Condition category
Condition code
Mental Health 2528 2528 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
continuous subcutaneous flumazenil infusion at rate of 4mg/24 hours for 4 days, followed by 24 hours observation after ceasing infusion
Intervention code [1] 2145 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3427 0
percentage of patients entering treatment who complete benzodiazepine withdrawal and cease using benzodiazepines
Timepoint [1] 3427 0
day 5 after commencing flumazenil infusion
Secondary outcome [1] 5691 0
quantitative severity of benzodiazepine withdrawal as measured by Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) withdrawal scale
Timepoint [1] 5691 0
daily for 5 days during treatment
Secondary outcome [2] 5692 0
percentage of patients entering treatment who develop local tissue reaction to infusion
Timepoint [2] 5692 0
daily for 5 days during treatment

Eligibility
Key inclusion criteria
benzodiazepine dependent (daily use of benzodiazepine > 3 months at diazepam equivalent of 10mg or greater, with withdrawal symptoms on attempted cessation); wishing to withdraw from, and cease using benzodiazepines; 18 years or older; not pregnant or breastfeeding
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18 years; pregnant or breastfeeding; unable or unwilling to give informed consent; medical condition that precludes cessation of benzodiazepine medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
all eligible, benzodiazepine dependent patients admitted to a community residential detoxification centre who wish to withdraw from benzodiazepines will be offered entry into the trial
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2677 0
Hospital
Name [1] 2677 0
St Vincent's, Melbourne
Country [1] 2677 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's, Melbourne
Address
PO Box 2900 Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 2418 0
None
Name [1] 2418 0
Address [1] 2418 0
Country [1] 2418 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4596 0
St Vincent's, Melbourne, Human Research Ethics Committee
Ethics committee address [1] 4596 0
PO Box 2900 Fitzroy Victoria 3065
Ethics committee country [1] 4596 0
Australia
Date submitted for ethics approval [1] 4596 0
08/10/2007
Approval date [1] 4596 0
Ethics approval number [1] 4596 0

Summary
Brief summary
Aim: This project will assess the safety, effectiveness and patient acceptability of administering the medication, flumazenil, to treat benzodiazepine dependence by means of subcutaneous (under the skin) infusion rather than by intravenous infusion.
Background: Benzodiazepines are a group of sedative drugs which are commonly prescribed for anxiety and insomnia. Examples include “valium”, “serepax”, and “mogadon”. Dependence on this group of drugs can occur rapidly with regular use, and successful withdrawal and treatment is very difficult. Long-term dependence on benzodiazepines, either prescribed or obtained illicitly through diversion, is therefore recognized as a major public health issue.
Current treatment for benzodiazepine dependence usually involves a slow reduction in the benzodiazepine dose over weeks, but is frequently unsuccessful because of the withdrawal symptoms of anxiety and agitation that occur, and so patients remain on benzodiazepines long-term. Flumazenil is a medication that has recently been successfully used to treat benzodiazepine dependence by giving it as an intravenous infusion over several days. Unfortunately, using this method of intravenous infusion is complex and resource intensive, and this limits the availability of this form of treatment for many patients.
This project is a pilot study to determine whether giving flumazenil by the simpler subcutaneous route would be an effective alternative that could make treatment available to many more patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28089 0
Address 28089 0
Country 28089 0
Phone 28089 0
Fax 28089 0
Email 28089 0
Contact person for public queries
Name 11246 0
Professor Jon Currie
Address 11246 0
PO Box 2900 Fitzroy Victoria 3065
Country 11246 0
Australia
Phone 11246 0
61 3 9288 3467
Fax 11246 0
61 3 9288 2642
Email 11246 0
[email protected]
Contact person for scientific queries
Name 2174 0
Professor Jon Currie
Address 2174 0
PO Box 2900 Fitzroy Victoria 3065
Country 2174 0
Australia
Phone 2174 0
61 3 9288 3467
Fax 2174 0
61 3 9288 2642
Email 2174 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

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

Documents added automatically
No additional documents have been identified.