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Trial registered on ANZCTR


Registration number
ACTRN12609000138280
Ethics application status
Approved
Date submitted
26/02/2009
Date registered
5/03/2009
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of unsupervised buprenorphine-naloxone versus wait list contol for heroin addiction
Scientific title
A randomised controlled trial to evaluate the effect of unsupervised buprenorphine-naloxone on heroin use in heroin addicts compared to heroin use in addicts who remain on the wait-list to receive opiate-substitution therapy.
Universal Trial Number (UTN)
Trial acronym
BPX01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heroin addiction 4393 0
Condition category
Condition code
Mental Health 4674 4674 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the treatment group will receive daily buprenorphine naloxone for a period of 3 months administered as tablets of Suboxone delviered sublingually. During week 1 of dosing, the daily dose will be escalated from 4mg up to 16mg per day and tolerability to the dose will be determined, The maximum tolerable daily dose level will then be given for the duration of the treatment period. Dose tolerability will also be continually reviewed and doses modfied as required during this period. Half of the initial dose of Suboxone tablets on the first day of treatment will be delivered to the patient in the clinic. For the remainder of the treatment period patients will be supplied with enough Suboxone tablets to enable them to self administer their own daily doses for the following week. At the commencement of each week during the treatment period patients will return to the clinic and be reviewed and receive enough take home doses for the following week of treatment.
Intervention code [1] 4153 0
Treatment: Drugs
Comparator / control treatment
The control / comparator group will be patients randomised to remain on the wait list to receive opiate substitution for a period of 3 months. At the completion of this period they will be offered methadone or buprenorphine treatment.
Control group
Active

Outcomes
Primary outcome [1] 5508 0
To determine if heroin users randomised to receive buprenorphine-naloxone have a greater reduction in heroin use compared to patients on a waiting list for methadone or buprenorphine maintenance treatment. Heroin use will be determined by self report using the Opiate Treatment Index Questionnaire (OTI), urine analysis for drugs of abuse content and hair analysis (conducted at baseline and 3 months only) for drugs of abuse content.
Timepoint [1] 5508 0
Baseline, end of one, two and three months.
Secondary outcome [1] 9271 0
Compare differences in the Quality of Life evaluation between the two groups. This will be assessed using the World Health Organisation Abbreviated Quality of Life Questionnaire (WHOQOL-BREF).
Timepoint [1] 9271 0
Baseline, end of one, two and three months
Secondary outcome [2] 9334 0
Compare differences in Psychosocial functioning between the two groups. Pyschosocial functioning in all study participants will be determined using the Short Form 12 (SF12) interview-style questionnaire. Psychological distress will be measured using the Kessler 10 (K10) questionnaire.
Timepoint [2] 9334 0
Baseline, end of one, two and three months
Secondary outcome [3] 9335 0
Compare the blood borne virus risk practices between the two groups using the Injecting and Sexual Practises domain of the Opiate Treatment Index (OTI) Questionnaire.
Timepoint [3] 9335 0
Baseline, end of one, two and three months

Eligibility
Key inclusion criteria
Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of heroin dependence disorder.
Recent heroin use (at least 20 days in the last month.
Stable accomodation within the local geographical area.
If female, willing to use contraception during the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pregnancy or breat feeding.
Children under 16 years at home with current Department of Community Services(DOCS) involvement.
Pending court hearings with a risk of custodial sentence.
Current DSMIV substance dependence to alcohol, benzodiazepines, amphetamines or cocaine.
Any Opiate Substitution Thearpy (OST) in the previous 4 weeks or more than 2 weeks consecutive OST in the previous 12 weeks.
Co-existing major medical or psychiatiric condistions where immediate OST and / or otehr treaments are warranted.

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)
potential study candidates will be identified from the OST wait list . Subjects will be provided with information regarding the study and informed consent will be sought. Eligibility criteria will then be evaluated and patients informed of their suitability for entry into the study. They will be randomly allocated to the treatment or wait-list group and informed on their group allocation. The treatment code for each patient will be written in a sealed envelope which the investigator / researcher will open following assessment of eligibility to determine group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of sequential group allocations will be randomly computer-generated using the randomisation tools on www.randomization.com. To avoid group bias to either investigative site a separate randomisation list will be generated for each study site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
28/04/2009
Date of last participant enrolment
Anticipated
Actual
13/10/2009
Date of last data collection
Anticipated
Actual
5/01/2010
Sample size
Target
50
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 1526 0
2300

Funding & Sponsors
Funding source category [1] 4594 0
Government body
Name [1] 4594 0
NSW Health Drug and ALcohol Research Sub-Committee Research and Health System Development
Country [1] 4594 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Area Health Service, Drug and Alcohol Clinical Services
Address
Newcastle Community Health Centre
Suite 8, 670 Hunter Street, Newcastle, 2300, NSW
Country
Australia
Secondary sponsor category [1] 4143 0
None
Name [1] 4143 0
Address [1] 4143 0
Country [1] 4143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6644 0
Hunter New England Area Health Service Human Research Ethics Committee
Ethics committee address [1] 6644 0
Administration Building
HNEAHS
Lookout Road
New Lambton
NSW 2305
Ethics committee country [1] 6644 0
Australia
Date submitted for ethics approval [1] 6644 0
Approval date [1] 6644 0
10/12/2008
Ethics approval number [1] 6644 0
08/10/15/3.05

Summary
Brief summary
The clinical trial would compare heroin use in a group of patients randomly allocated to receive unsupervised dosing with buprenorphine-naloxone to a group of patients remaining on wait list for a 12 week period (when this group would then be offered substitution treatment). The study will also assess adverse events that may be related to providing unsupervised dosing with buprenorphine-naloxone.
Trial website
Trial related presentations / publications
Associated manuscript submitted and currently under review with the Drug And Alcohol Dependence Journal
Public notes

Contacts
Principal investigator
Name 29329 0
Prof Adrian Dunlop
Address 29329 0
Newcastle Community Health Centre, Suite 8, Level 3, 670 Hunter St, NEWCASTLE 2300, NSW
Country 29329 0
Australia
Phone 29329 0
+61 2 49 4016 4664
Fax 29329 0
Email 29329 0
[email protected]
Contact person for public queries
Name 12576 0
Dr. Adrian Dunlop
Address 12576 0
Hunter New England Area Health Service
Drug and Alcohol Clinical Services
Management Unit
Newcastle Community Centre
Suite 8, 670 Hunter Street
Newcastle, 2300
NSW
Country 12576 0
Australia
Phone 12576 0
+61 2 401 64664
Fax 12576 0
+61 2 401 64661
Email 12576 0
[email protected]
Contact person for scientific queries
Name 3504 0
Dr. Adrian Dunlop
Address 3504 0
Hunter New England Area Health Service
Drug and Alcohol Clinical Services
Management Unit
Newcastle Community Centre
Suite 8, 670 Hunter Street
Newcastle, 2300
NSW
Country 3504 0
Australia
Phone 3504 0
+61 2 401 64664
Fax 3504 0
+61 2 401 64661
Email 3504 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness and cost-effectiveness of unsupervised buprenorphine-naloxone for the treatment of heroin dependence in a randomized waitlist controlled trial.2017https://dx.doi.org/10.1016/j.drugalcdep.2017.01.016
N.B. These documents automatically identified may not have been verified by the study sponsor.