Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000691640
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
26/10/2005
Date last updated
26/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Role of Cognitive Behaviour Therapy in Cessation of Long Term Benzodiazepine Use and Outcome at 6 months
Scientific title
The Role of Cognitive Behaviour Therapy in Cessation of Long Term Benzodiazepine Use and Outcome at 6 months
Universal Trial Number (UTN)
Trial acronym
Benzo withdrawal program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long term benzodiazepine use 840 0
Condition category
Condition code
Other 907 907 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 - Benzodiazepine dose reduction program initiated by General Practitioner plus immediate delivery of correspondence psychological skills program. Dose reduction is patient controlled and may take upto six months to cease use.

Group 2 - Benzodiazepine dose reduction program initiated by General Practitioner plus 3 mths delayed delivery of correspondence psychological skills program. Dose reduction is patient controlled and may take upto six months to cease use.
Intervention code [1] 658 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1181 0
Cessation of benzodiazepine use
Timepoint [1] 1181 0
Assessed from continuous weekly self monitoring reports, and confirmed with the GP at interviews held at post-cessation.
Secondary outcome [1] 2158 0
50% reduction of benzodiazepinedaily dose at follow-up.
Timepoint [1] 2158 0
At six months.

Eligibility
Key inclusion criteria
a) have been receiving a daily dose of a benzodiazepine for a minimum continuous period of 3 months; and b) are on a stable maintenance dose of a benzodiazepine at the time of entry into the study (5-40 mg/day of diazepam or its equivalent).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) have a current diagnosis of a psychotic disorder;b) are diagnosed with a gross brain disorder;c) have concurrent alcohol or other non-benzodiazepine drug dependence; d) are in current receipt of any other psychological treatment; or e) are pregnant or nursing.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated by computer software into 20 sequences of blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1000 0
Government body
Name [1] 1000 0
Queensland Health
Country [1] 1000 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Country
Australia
Secondary sponsor category [1] 861 0
University
Name [1] 861 0
University of Queensland
Address [1] 861 0
Country [1] 861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2306 0
Royal Australian College of General Practice
Ethics committee address [1] 2306 0
Ethics committee country [1] 2306 0
Australia
Date submitted for ethics approval [1] 2306 0
Approval date [1] 2306 0
Ethics approval number [1] 2306 0
Ethics committee name [2] 2307 0
Cairns Base Hospital
Ethics committee address [2] 2307 0
Ethics committee country [2] 2307 0
Australia
Date submitted for ethics approval [2] 2307 0
Approval date [2] 2307 0
Ethics approval number [2] 2307 0
Ethics committee name [3] 2308 0
University of Queensland
Ethics committee address [3] 2308 0
Ethics committee country [3] 2308 0
Australia
Date submitted for ethics approval [3] 2308 0
Approval date [3] 2308 0
Ethics approval number [3] 2308 0
Ethics committee name [4] 2309 0
Princes Alexandra Hospital
Ethics committee address [4] 2309 0
Ethics committee country [4] 2309 0
Australia
Date submitted for ethics approval [4] 2309 0
Approval date [4] 2309 0
Ethics approval number [4] 2309 0
Ethics committee name [5] 2310 0
Prince Charles Hospital
Ethics committee address [5] 2310 0
Ethics committee country [5] 2310 0
Australia
Date submitted for ethics approval [5] 2310 0
Approval date [5] 2310 0
Ethics approval number [5] 2310 0

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

Contacts
Principal investigator
Name 35437 0
Address 35437 0
Country 35437 0
Phone 35437 0
Fax 35437 0
Email 35437 0
Contact person for public queries
Name 9847 0
Jan Parr
Address 9847 0
Alcohol, Tobacco and Other Drugs Service
Queensland Health
PO Box 1336
Cairns QLD 4870
Country 9847 0
Australia
Phone 9847 0
+61 7 40503900
Fax 9847 0
+61 7 40514151
Email 9847 0
[email protected]
Contact person for scientific queries
Name 775 0
Jan Parr
Address 775 0
Alcohol, Tobacco and Other Drugs Service
Queensland Health
PO Box 1336
Cairns QLD 4870
Country 775 0
Australia
Phone 775 0
+61 7 40503900
Fax 775 0
+61 7 40514151
Email 775 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.