Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000039381
Ethics application status
Not yet submitted
Date submitted
16/01/2008
Date registered
23/01/2008
Date last updated
2/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An open label cross-over study of direct transfers between methadone and buprenorphine maintenance
Scientific title
An open label cross-over study of the effect of direct transfers between methadone and buprenorphine maintenance on sleep, cognitive, endocrine and cardio-respiratory function.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heroin dependence 2726 0
Condition category
Condition code
Mental Health 2851 2851 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Thirty opioid maintenance patients who are seeking to switch between methadone and buprenorphine/naloxone will be tested pre and post transfer on a range of clinical outcomes including sleep function, cognitive function, endocrine function, cardio-respiratory function and driving performance. Methadone is a full opioid agonist with a usual daily maintainence dose of 30-80 mg taken orally. Buprenorphine is a partial opioid agonist taken sublingually up to a maximum of 32 mg. Doses vary according to individual. The duration of the study follow up is 3 months.
Intervention code [1] 2466 0
Treatment: Drugs
Comparator / control treatment
Within subjects design. Subjects act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 3732 0
Range of domains and instruments.For cognitive testing we will be using the Coninuous Performace test, the Stroop Clor-Word Test, Trail Making Tests, Letter Numbering and Digital span. Sllep functionng will be test under laboratory conditions with polysomnography, blood topxiocology, cardiovascular and respiratory responses to hypoxia and hypercapnia. Driving performance will be tested on a motor vehicle simulator. Endcocrine function will be examined through self-rated questionnaires and plasma hormone evels.
Timepoint [1] 3732 0
One month pre transfer, one month post transfer with final 3 month follow up
Secondary outcome [1] 6304 0
Craving, retention, substance use and with drawal. Self rated scales.
Timepoint [1] 6304 0
One month pre transfer, one month post transfer with final 3 month follow up

Eligibility
Key inclusion criteria
Stable methadone or buprenorphine treatment > 2 months, seeking to transfer to an alteernate opioid maintenance.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active or uncontrolled severe psychiatric illness or medical problems. No other current drug dependence or withdrawal iisues. Pregnancy.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2980 0
Commercial sector/Industry
Name [1] 2980 0
Reckitt Benckiser
Country [1] 2980 0
Australia
Primary sponsor type
Hospital
Name
Langton Centre
Address
591 South Dowling Street
Surry Hills NSW 2010
Country
Australia
Secondary sponsor category [1] 2690 0
Hospital
Name [1] 2690 0
Royal Prince Alfred Hospital
Address [1] 2690 0
Drug and Alcohol Services
Missenden Road
Camperdown NSW 2042
Country [1] 2690 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4933 0
Ethics committee address [1] 4933 0
Ethics committee country [1] 4933 0
Date submitted for ethics approval [1] 4933 0
01/12/2007
Approval date [1] 4933 0
Ethics approval number [1] 4933 0

Summary
Brief summary
This project is designed to examine whether opiate subsititution on table doses of methadone or buprenorphine differentiall affect clinical outcomes (i.e. drug use), cognitive function (i.e. attention), endocirne function (i.e. libido), cardio-respiratory function (i.e. heart rate), sleep function (sleep activity) and driving skills.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28306 0
Address 28306 0
Country 28306 0
Phone 28306 0
Fax 28306 0
Email 28306 0
Contact person for public queries
Name 11463 0
James Shearer
Address 11463 0
Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
Country 11463 0
Australia
Phone 11463 0
02 9332 8777
Fax 11463 0
Email 11463 0
james.shearer@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 2391 0
Nick Lintzeris
Address 2391 0
Alcohol and Drug Services
Royal Prince Alfred Hospital
Camperdown NSW 2042
Country 2391 0
Australia
Phone 2391 0
02 9332 8777
Fax 2391 0
Email 2391 0
nicholas.lintzeris@sswahs.nsw.gov.au

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.