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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
Scientific title
A randomised trial of effective and cost effectiveness of supervised versus unsupervised administration of buprenorphine-naloxone for heroin dependence
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heroin dependence 1826 0
Condition category
Condition code
Mental Health 1918 1918 0 0
Addiction

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 628 0
Treatment: Other
Comparator / control treatment
Control intervention is sublingual Buprenorphine-naloxone adminstered daily under supervision, weekly case management and monthly medical review.
Control group
Active

Outcomes
Primary outcome [1] 2729 0
Retention in treatment
Timepoint [1] 2729 0
At 3 and 6 months
Primary outcome [2] 2730 0
Heroin use
Timepoint [2] 2730 0
At 3 months
Primary outcome [3] 2731 0
Cost effectiveness
Timepoint [3] 2731 0
At 3 months as measured by incremental cost per additional day free of opioid use
Secondary outcome [1] 4605 0
Heroin use
Timepoint [1] 4605 0
At 6 months.
Secondary outcome [2] 4606 0
Other drug use
Timepoint [2] 4606 0
At 3 and 6 months.
Secondary outcome [3] 4607 0
Injection of suboxone, staff assessment of treatment, participation in any treatment.
Timepoint [3] 4607 0
At 3 and 6 months

Eligibility
Key inclusion criteria
DSM-IV diagnosis of heroin dependence. 12 month history of dependence. Stable housing.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
Centralised randomisation by telephone
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2063 0
Commercial sector/Industry
Name [1] 2063 0
Reckitt Benckiser
Address [1] 2063 0
Country [1] 2063 0
Funding source category [2] 2064 0
Government body
Name [2] 2064 0
Centre for Drug & Alcohol, NSW Health
Address [2] 2064 0
Country [2] 2064 0
Australia
Primary sponsor type
Hospital
Name
Langton Centre
Address
Country
Australia
Secondary sponsor category [1] 1869 0
Commercial sector/Industry
Name [1] 1869 0
Reckitt Benckiser provided supplies of the study drug and a small amount of funding for participant reimbursement.
Address [1] 1869 0
Country [1] 1869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3833 0
Langton Centre approved by South Eastern Sydney Area Health Service HREC
Ethics committee address [1] 3833 0
Ethics committee country [1] 3833 0
Australia
Date submitted for ethics approval [1] 3833 0
Approval date [1] 3833 0
Ethics approval number [1] 3833 0
03/222
Ethics committee name [2] 3834 0
Bankstown Drug Health Service approved by South Western Sydney Area Health Service HREC
Ethics committee address [2] 3834 0
Ethics committee country [2] 3834 0
Australia
Date submitted for ethics approval [2] 3834 0
Approval date [2] 3834 0
07/01/2004
Ethics approval number [2] 3834 0
03/149
Ethics committee name [3] 3835 0
Turning Point approved by Victorian Deptartment of Human Services HREC.
Ethics committee address [3] 3835 0
Ethics committee country [3] 3835 0
Australia
Date submitted for ethics approval [3] 3835 0
Approval date [3] 3835 0
Ethics approval number [3] 3835 0
Ethics committee name [4] 3836 0
Newcastle Drug Health Service approved by Hunter Area Health Service HREC.
Ethics committee address [4] 3836 0
Ethics committee country [4] 3836 0
Australia
Date submitted for ethics approval [4] 3836 0
Approval date [4] 3836 0
Ethics approval number [4] 3836 0

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35187 0
Address 35187 0
Country 35187 0
Phone 35187 0
Fax 35187 0
Email 35187 0
Contact person for public queries
Name 9817 0
Ms. Carolyn Mutch
Address 9817 0
The Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
Country 9817 0
Australia
Phone 9817 0
+61 2 93328777
Fax 9817 0
Email 9817 0
mutchc@sesahs.nsw.gov.au
Contact person for scientific queries
Name 745 0
Associate Professor James Bell
Address 745 0
The Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
Country 745 0
Australia
Phone 745 0
+61 2 93328777
Fax 745 0
Email 745 0
bellj@sesahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary