Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000033549
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
25/01/2006
Date last updated
25/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
TDM in MMT
Scientific title
A trial of Therapeutic Drug Monitoring (TDM) in methadone treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opiod dependence 996 0
Condition category
Condition code
Mental Health 1071 1071 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomised to either the TDM group or to usual care. Each group will receive the same schedule of appointments for case management and three-monthly testing sessions. The usual care group will receive usual care from their clinic medical officer, including being able to request case increments. The TDM group will be transferred to the care of a study medical officer for 6 months, and be prescribed dose increments to achieve a trough plasma R-methadone concentration of 100ng/ml. Any subject in the TDM group already at 100ng/ml will have their trough concentrations raised to 200ng/ml using standard clinic protocols for dose increments. Patients will be monitored throughout for signs of adverse effects and dose changes will be adjusted accordingly under the supervision of an experienced senior medical officer. After targeted dose increments, trough concentrations will be measured again at 6 weeks and a final dose adjustment made. Testing sessions will be at 3 and 6 months and involve 2 days of observation.
Intervention code [1] 197 0
Treatment: Other
Comparator / control treatment
Usual care
Control group
Dose comparison

Outcomes
Primary outcome [1] 1434 0
Heroin use
Timepoint [1] 1434 0
At 3 and 6 months
Secondary outcome [1] 2539 0
Plasma R- and S- methadone concentrations
Timepoint [1] 2539 0
At 3 and 6 months.

Eligibility
Key inclusion criteria
Agree to and be capable of signing an informed consent form.In treatment at least 2 monthsOn a stable methadone dose for at least 4 weeksOn a methadone dose greater than or equal to 50mg/dayUse heroin 4 times or more in the last monthCurrent methadone prescriber consents to subject's participation in the research.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Considered unwilling, unable or unlikely to comply with the study protocolPregnant or breast feedingUsing drugs and dietary components known to interact with methadone pharmacokinetics (including antipsychotics, fluvoxamine, St John's Wort, Grapefruit juice)Unstable medical conditions (liver disease with jaundico/ascites/encephalopathy, structural heart disease, psychosis.

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)
Ransomisation conducted by Health Information Manager
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, random sequence generated by www.random.org
Masking / blinding
Blinded (masking 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
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1171 0
Government body
Name [1] 1171 0
National Health and Medical Research Council Project Grant 349536
Country [1] 1171 0
Australia
Primary sponsor type
Hospital
Name
The Langton Centre
Address
Country
Australia
Secondary sponsor category [1] 1032 0
University
Name [1] 1032 0
Department of Clinical and Experimental Pharmacology, University of Adelaide;
Address [1] 1032 0
Country [1] 1032 0
Australia
Secondary sponsor category [2] 1033 0
Charities/Societies/Foundations
Name [2] 1033 0
Waranilla Clinic, Drug and Alcohol Services Council, SA
Address [2] 1033 0
Country [2] 1033 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2490 0
South Eastern Sydney Area Health Service HREC- Eastern Section
Ethics committee address [1] 2490 0
Ethics committee country [1] 2490 0
Australia
Date submitted for ethics approval [1] 2490 0
Approval date [1] 2490 0
Ethics approval number [1] 2490 0
Ethics committee name [2] 2491 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 2491 0
Ethics committee country [2] 2491 0
Australia
Date submitted for ethics approval [2] 2491 0
Approval date [2] 2491 0
Ethics approval number [2] 2491 0

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

Contacts
Principal investigator
Name 35400 0
Address 35400 0
Country 35400 0
Phone 35400 0
Fax 35400 0
Email 35400 0
Contact person for public queries
Name 9386 0
Ms Anni Ryan
Address 9386 0
The Langton Centre
591 South Dowling St
Surry Hills NSW 2010
Country 9386 0
Australia
Phone 9386 0
+61 2 93328777
Fax 9386 0
+61 2 93328700
Email 9386 0
ryananni@sesiahs.nsw.gov.au
Contact person for scientific queries
Name 314 0
Dr James Bell
Address 314 0
The Langton Centre
591 South Dowling St
Surry Hills NSW 2010
Country 314 0
Australia
Phone 314 0
+61 2 93328777
Fax 314 0
+61 2 93328700
Email 314 0
bellj@sesahs.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.