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Trial registered on ANZCTR
Registration number
ACTRN12607000285459
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
29/05/2007
Date last updated
29/05/2007
Type of registration
Retrospectively registered
Titles & IDs
Public title
A randomised trial of effective and cost effectiveness of supervised versus unsupervised administration of buprenorphine-naloxone for heroin dependence
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Scientific title
A randomised trial of effective and cost effectiveness of supervised versus unsupervised administration of buprenorphine-naloxone for heroin dependence
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heroin dependence
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Condition category
Condition code
Mental Health
1918
1918
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention is sublingual bupernorphine-naloxone dispensed weekly i.e. not administered daily under supervision, weekly case management and monthly medical review. The duration of the randomised intervention is 3 months. At 3 months participants randomised to daily supervised administration who are clinically assessed as stable are transferred to weekly dispensed medication for a further 3 months. Similarly, those randomised to weekly dispensed medication who are clinically assessed as not being stable are transferred to weekly supervised administration for a further 3 months. Criteria for assessing stability is:
1. No evidence of unstable drug use, as defined by:
a) Use of heroin, amphetamines and or cocaine on >4 occasions per month
b) Daily average alcohol intake >60g alcohol
c) Episodic or regular intoxication with benzodiazepines
These are assessed by self-report, clinical examination, record of presentations intoxicated, and urine drug screening.
2. No risk factors for safety as evidenced by:
a) Unstable accommodation and living arrangements (for example, partners /flatmates who are actively injecting, unsatisfactory storage facilities)
b) Medical or psychiatric instability (assessed moderate risk of self-harm [depression with suicidal ideation], psychosis, decompensated liver disease, cognitive impairment which might make unsupervised medication unsafe)
c) Children < 4 about whom there is DOCS involvement regarding parenting and in whom high levels of supervision and monitoring are thought to be in the child’s interest
3. Any evidence of diversion
Dose is individually determined i.e. in keeping with usual care dosage is titrated for each patient.
Please note the study factor is unsupervised administration i.e. the mode of administration not the medication or dosage itself.
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Intervention code [1]
628
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Treatment: Other
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Comparator / control treatment
Control intervention is sublingual Buprenorphine-naloxone adminstered daily under supervision, weekly case management and monthly medical review.
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Control group
Active
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Outcomes
Primary outcome [1]
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Retention in treatment
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Assessment method [1]
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Timepoint [1]
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At 3 and 6 months
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Primary outcome [2]
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Heroin use
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Assessment method [2]
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Timepoint [2]
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At 3 months
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Primary outcome [3]
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Cost effectiveness
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Assessment method [3]
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Timepoint [3]
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At 3 months as measured by incremental cost per additional day free of opioid use
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Secondary outcome [1]
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Heroin use
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Assessment method [1]
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Timepoint [1]
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At 6 months.
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Secondary outcome [2]
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Other drug use
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Assessment method [2]
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Timepoint [2]
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At 3 and 6 months.
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Secondary outcome [3]
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Injection of suboxone, staff assessment of treatment, participation in any treatment.
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Assessment method [3]
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Timepoint [3]
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At 3 and 6 months
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Eligibility
Key inclusion criteria
DSM-IV diagnosis of heroin dependence. 12 month history of dependence. Stable housing.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Dependence on alcohol, amphetamines, or benzodiazepines.Major medical or psychiatric conditions. Methadone or buprenorphine treatment in the past month. Risk of incarceration.Pregnant/planning pregnancy. Previous enrolment in study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation by telephone
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Identical envelopes containing group allocation randomly selected from a box to create a randomisation list prior to trial commencement. the list was held off-site at Sydney Hospital pharmacy
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/01/2004
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
146
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Accrual to date
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Final
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Reckitt Benckiser
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Address [1]
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Country [1]
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Funding source category [2]
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Government body
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Name [2]
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Centre for Drug & Alcohol, NSW Health
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Address [2]
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Country [2]
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Australia
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Primary sponsor type
Hospital
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Name
Langton Centre
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Address
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Reckitt Benckiser provided supplies of the study drug and a small amount of funding for participant reimbursement.
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Address [1]
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Country [1]
1869
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Langton Centre approved by South Eastern Sydney Area Health Service HREC
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
3833
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Approval date [1]
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Ethics approval number [1]
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03/222
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Ethics committee name [2]
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Bankstown Drug Health Service approved by South Western Sydney Area Health Service HREC
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Ethics committee address [2]
3834
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
3834
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Approval date [2]
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07/01/2004
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Ethics approval number [2]
3834
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03/149
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Ethics committee name [3]
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Turning Point approved by Victorian Deptartment of Human Services HREC.
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Ethics committee address [3]
3835
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
3835
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Approval date [3]
3835
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Ethics approval number [3]
3835
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Ethics committee name [4]
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Newcastle Drug Health Service approved by Hunter Area Health Service HREC.
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Ethics committee address [4]
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
3836
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Approval date [4]
3836
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Ethics approval number [4]
3836
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Summary
Brief summary
The primary purpose of the study is to compare the effectiveness and cost-effectiveness of combination buprenorphine-naloxone (Suboxone) in the treatment of heroin dependence under two conditions – supervised and unsupervised administration. The defining characteristic of methadone and buprenorphine treatment in Australia is that patients attend a clinic or pharmacy daily for supervised administration of the prescribed opioid.
The study hypotheses are:
1. unsupervised administration will be associated with superior retention compared to supervised administration
2.unsupervised administration will be more cost effective than supervised administration
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ms. Carolyn Mutch
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Address
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The Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
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Country
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Australia
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Phone
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+61 2 93328777
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Associate Professor James Bell
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Address
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The Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
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Country
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Australia
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Phone
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+61 2 93328777
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Fax
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Email
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[email protected]
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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.
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